110 Clinical Director jobs in Saint Paul
Director of Nursing RN Full Time (Minneapolis)
Posted 12 days ago
Job Viewed
Job Description
Join our not-for-profit organization that has provided over 100 years of housing and services to seniors with a commitment to quality care and service in a Christian environment.
Facility: GSS MN Luverne
Shift: Day
Job Schedule: Full time
20,000 Sign-on Bonus!
Administers the nursing program in a long term care facility to maintain standards of resident care. Facilitates the optimization of the geriatric care process to improve the quality and efficiency of service. Responsible for the overall quality of care provided by the organization's nursing personnel. Advises medical staff, department heads, and administrators in matters related to nursing service and strategies. Interprets policies and objectives of nursing service to staff and community groups. Monitors the operations of the nursing staff and ensures compliance with regulations on organizational and governmental standards and practices. Schedules staff and conducts employee performance reviews. Provides nursing care to residents on an as needed basis. Assists in the development and implementation of marketing activities/programs inclusive of community activities, special events and media activities.
Has overall responsibility for the day-to-day operations of long term care facility. Includes quality of resident care, program/care management, environmental safety, budget constraints and responding to identified needs to ensure regulatory compliance. Maintains communication and addresses the rapidly changing healthcare environment in which clinical services are delivered across the system. Leads the development and execution of clinical programs, policies, procedures and protocols ensuring system integration and adherence of clinical programs, policies, procedures and protocols ensuring system integration and adherence. Monitors operations of nursing staff and ensures compliance with regulations on organizational and governmental standards and practices.
Bachelor's degree in nursing preferred, but not required.
Graduate from a nationally accredited nursing program preferred, including, but not limited to, Commission on Collegiate Nursing Education (CCNE), Accreditation Commission for Education in Nursing (ACEN), and National League for Nursing Commission for Nursing Education Accreditation (NLN CNEA).
For Rural Health Network facilities and Good Samaritan Society (GSS) locations only, employees who do not possess a Bachelor’s degree, leadership may consider an educational plan with proven continuous action toward achieving a Bachelor’s degree within five years of hire into position. Additionally for Rural Health Network facilities Good Samaritan Society (GSS) locations, for current employees, leadership may have considered acceptable qualifications and work experience equivalency based on facility size, rural market, and business need, prior to new Sanford education requirements.
Five years nursing experience required. Housing with Services, housing and urban development (HUD), and/or assisted living experience also helpful. Thorough knowledge of the nursing practice act and standards of nursing care, and a working knowledge of administrative and management techniques.
Currently holds an unencumbered RN license with the State Board of Nursing where the practice of nursing is occurring
and/or possess multistate licensure if in a Nurse Licensure Compact (NLC) state. The Good Samaritan offers an attractive benefits package for qualifying full-time and part-time employees. Depending on eligibility, a variety of benefits include health insurance, dental insurance, vision insurance, life insurance, a 401(k) retirement plan, work/life balance benefits, and a generous time off package to maintain a healthy home-work balance. The Good Samaritan is an EEO/AA Employer M/F/Disability/Vet. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1- or send an email to Good Samaritan has a Drug Free Workplace Policy. Job Function: Nursing
Director, Clinical Operations
Posted 10 days ago
Job Viewed
Job Description
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Position Summary** **:**
Is responsible for the implementation and oversight of clinical study operations by organizing and coordinating with other relevant parties the planning, implementation, management, execution and completion of clinical studies according to applicable regulations and guidance, ICH and GCP, and Bausch & Lomb SOPs within agreed-upon timeframes and budget. Also responsible for effective communication within the corporation (and with external entities, where appropriate) of the issues and actions related to the successful completion of these studies. May serve as the primary project team representative for Clinical Operations.
**Major areas of Responsibility** **:**
Clinical Operations:
+ Manage and/or oversee the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs). Will also work closely with members of other functional areas to provide input on study-related documents and issues (DMP, SAP, drug/device supplies, CSR, etc.).
+ Provides clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS, etc.).
+ Manage the identification, evaluation, and selection of investigators/sites.
+ Ongoing assessment, evaluation and management of internal and external resources.
+ Ensure study supply requirements are met.
+ Responsible for the appropriate communication with and maintenance of clinical study sites including training of site personnel in the study protocol and other study-specific procedures.
+ Supervise clinical operations team to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and B&L SOPs.
+ Communicate with relevant global team members, other B&L departments (e.g., R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device Safety, and Clinical Supplies), and external consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes in scope, schedule, and resources.
+ Organize investigator and expert meetings relevant to the indication and assist with the organization and management of DSMBs and Data Review Committees, as necessary.
+ Prepare study timelines and budgets and ensuring study execution is aligned with these targets.
+ Supervise clinical staff and vendors to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and B&L SOPs.
+ Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.) during study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner.
+ Oversee the preparation of procedures for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, procedures for reporting of adverse events, CRF completion guidelines, Study Manual, etc.
+ Liaise with PVG/GPSS and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs and assure proper reporting of the events to the IRBs/REBs/ECs.
+ Liaise with Data Management to review data discrepancies and ensure that data clarification forms (queries) are appropriately handled by the CRAs and responded to by the site/investigator in a timely manner. May assist in the review of queries to determine criticality of the DCF during data clean-up and lock process.
+ Liaise with vendors and study site personnel and clinical investigators to provide study related guidance and answers to operational issues.
Budgets and Forecasts:
+ Provide input to Finance to forecast study expenditures and resourcing needs.
+ Review RFPs and proposals from external vendors.
+ Ensure subordinates and vendors manage and monitor study related expenses to meet forecast.
Regulatory Reports:
+ Provide Clinical Operations support in the timely coordination and execution of clinical study reports.
+ Assist in the review of regulatory reports to ensure that reports accurately reflect proper interpretation of the clinical study findings.
+ Assist to ensure annual IND/IDE and IB/ROPI updates are completed in an accurate and timely manner.
+ Provide Clinical Operations support to the Regulatory Affairs department.
Leadership:
+ Manage in-house team of CRAs, CTAs and/or CTMs for one or more studies to ensure execution of all studies in a timely and efficient manner.
+ Provide leadership, training, and development support to the study team.
+ May lead meetings (face-to-face, teleconferences, etc.) with external vendors ensuring problems are identified and issues are resolved quickly and efficiently.
+ May serve as a representative on internal committees/teams for Clinical Operations or cross-functional activities.
+ Foster a dynamic, matrixed working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging study team members to meet and/or exceed expectations.
+ Encourage professional growth of personnel through regular training sessions, and by acting as a resource to clinical staff. May lead training sessions.
+ Provide guidance and comments on SOPs revisions. May act as a leader of a SOP sub-committee for SOP revisions.
+ May visit sites with CRAs as needed to provide hands-on training as well as to discuss study related issues and problems with the Principal Investigator and/or site staff.
+ Share/present knowledge and information with appropriate departmental, project, or study team members for training purposes.
**POSITION REQUIREMENTS** **:**
+ Strong knowledge of Good Clinical Practices (GCP), clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management.
+ Minimum 10-12 years experience in the industry with a minimum of 6 years of managing clinical trials.
+ Minimum of 5 - 6 years experience in managing and training clinical personnel (Executive CRAs, CRAs, project assistants).
+ Experience leading device studies in Ophthalmology is a plus
+ Strong planning and organizational skills with ability to multi-task and plan activities as it relates to management of clinical trials.
+ Experience leading and working within cross-functional teams.
+ Experience in managing CROs and external vendors.
+ Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, outside vendors, consultants, team members and various audiences.
+ Ability to problem solve, build teams, and to lead and motivate others.
+ Effectively work independently as well as within a team matrix.
+ Financial management skills as applicable to overseeing project expenditures and forecasts.
+ Advanced computer skills (Microsoft applications, spreadsheets and data displays, etc.)
+ Willing and able to travel.
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off - vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s): ((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $170,000.00 and $205,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Bausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs:Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Associate Director, Clinical Research
Posted 1 day ago
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Associate Director, Clinical Research
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
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Career development with an international company where you can grow the career you dream of.
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Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
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An excellent retirement savings plan with a high employer contribution
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Tuition reimbursement, the Freedom 2 Save ( student debt program, and FreeU ( education benefit - an affordable and convenient path to getting a bachelor's degree.
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A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
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A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Plymouth or St Paul, MN location for our Electrophysiology Medical Device business. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
This role will plan and manage multiple or complex Clinical Affairs Program(s) across all functional areas, within budget and timelines. Represents Clinical Affairs function at Clinical Advisory Board meetings, interactions with Regulatory Agencies, and for evaluation of business opportunities including due diligence.
What You'll Work On
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Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
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Budgetary responsibility for cost center or Clinical Affairs program. Ensure development of accurate budgets, contract development and execution, payments and tracking of study, clinical evaluation, and/or risk management expenditure as directed by your manager.
-
Management of personnel development, mentoring and effective delegation to direct reports to meet program goals. Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to senior staff. Manage performance management process for the team.
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Accountable for strategy development and execution for specified clinical area.
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Effective coordination of all functional areas involved in the clinical program to solve problems and assure progress and timely completion of program goals.
-
Critical review of vendor proposals and contracts to include potential CRO agreements and medical writers to ensure program success. Financial approval of contracts and expenses at specified level.
-
Prioritization across teams to ensure strategic goals/milestones within Clinical Affairs are met.
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Develops and maintains current, in-depth, relevant functional knowledge (such as scientific, technical and regulatory aspects) of projects in support of the diagnostic area on a global basis.
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Builds and maintains relationships with key experts and professional organizations that further the effective development of the product and maximize product potential.
-
Collaborates with functional management to ensure an appropriate functional spokesperson for the project is identified to interact with relevant stakeholders, including R&D, Regulatory Affairs, commercial management, external experts and professional organizations and regulatory agencies.
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Leads and motivates functional area teams to meet key project deliverables and timelines by developing effective technical strategies, and collaborating with functional management to coordinate tactical execution by sub team members and functional organizations.
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Drives short- and long-term project success by managing and monitoring the functional components of worldwide projects such that scientific, regulatory, legal, financial, commercial and quality requirements are met in consideration of time and resource constraints as well as environmental uncertainties while operating by and within standardized procedures established within the function.
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Uses thoroughly analyzed data, due diligence, and input from internal and external functional experts to drive a rigorous decision-making process that appropriately incorporates underlying assumptions, risks and benefits, probabilities of success, timelines, and resource requirements.
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Effectively manages team members and deliverables in times of conflict, uncertainty and crisis, and resolve issues in a timely manner in conjunction with functional management. Fosters creative thinking, innovation, knowledge sharing and reasoned risk-taking.
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Ensures appropriate review and refinement of project plans by functional area management and staff.
-
Clearly communicates project/program recommendations and decisions to various stakeholders within the team, functional areas, R&D, and commercial management.
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Appropriately disseminates feedback from governance bodies and the functions to the team and extended organization.
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Acts on appropriate feedback from worldwide project team stakeholders and functional management to optimize performance as worldwide project team core team member. Program/development strategy/direct line management and research matrix management - Clinical Affairs representative for worldwide project team.
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Daily interaction with Sr. Management in multiple cross-functional areas, including finance, R&D, and regulatory affairs. - Manages internal organization/department within larger Clinical organization in a cross-functional environment. - Responsible for setting direction, creating/managing budget, prioritization, staff management and development.
Required Qualifications
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Education: Bachelors Degree in related field OR an equivalent combination of education and work experience
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Minimum 10 years Related work experience in clinical research; preferred industry experience in medical device or pharma.
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IDE, risk management, and/or clinical evaluation experience required.
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Management experience in other clinical operations and/or regulatory affairs positions.
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Global experience preferred.
What We Offer
At Abbott, you can have a good job that can grow into a great career. We offer:
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A fast-paced work environment where your safety is our priority
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Production areas that are clean, well-lit and temperature-controlled
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Training and career development , with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Apply Now (
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: (
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at , and on X @AbbottNews.
The base pay for this position is $127,300.00 - $254,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Associate Director, Clinical Research
Posted 3 days ago
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Associate Director, Clinical ResearchWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream of.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with a high employer contributionTuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.The Opportunity This position works out of our Plymouth or St Paul, MN location for our Electrophysiology Medical Device business. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.This role will plan and manage multiple or complex Clinical Affairs Program(s) across all functional areas, within budget and timelines. Represents Clinical Affairs function at Clinical Advisory Board meetings, interactions with Regulatory Agencies, and for evaluation of business opportunities including due diligence.What You'll Work OnResponsible for compliance with applicable Corporate and Divisional Policies and procedures.Budgetary responsibility for cost center or Clinical Affairs program. Ensure development of accurate budgets, contract development and execution, payments and tracking of study, clinical evaluation, and/or risk management expenditure as directed by your manager.Management of personnel development, mentoring and effective delegation to direct reports to meet program goals. Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to senior staff. Manage performance management process for the team.Accountable for strategy development and execution for specified clinical area.Effective coordination of all functional areas involved in the clinical program to solve problems and assure progress and timely completion of program goals.Critical review of vendor proposals and contracts to include potential CRO agreements and medical writers to ensure program success. Financial approval of contracts and expenses at specified level.Prioritization across teams to ensure strategic goals/milestones within Clinical Affairs are met.Develops and maintains current, in-depth, relevant functional knowledge (such as scientific, technical and regulatory aspects) of projects in support of the diagnostic area on a global basis.Builds and maintains relationships with key experts and professional organizations that further the effective development of the product and maximize product potential.Collaborates with functional management to ensure an appropriate functional spokesperson for the project is identified to interact with relevant stakeholders, including R&D, Regulatory Affairs, commercial management, external experts and professional organizations and regulatory agencies.Leads and motivates functional area teams to meet key project deliverables and timelines by developing effective technical strategies, and collaborating with functional management to coordinate tactical execution by sub team members and functional organizations.Drives short- and long-term project success by managing and monitoring the functional components of worldwide projects such that scientific, regulatory, legal, financial, commercial and quality requirements are met in consideration of time and resource constraints as well as environmental uncertainties while operating by and within standardized procedures established within the function.Uses thoroughly analyzed data, due diligence, and input from internal and external functional experts to drive a rigorous decision-making process that appropriately incorporates underlying assumptions, risks and benefits, probabilities of success, timelines, and resource requirements.Effectively manages team members and deliverables in times of conflict, uncertainty and crisis, and resolve issues in a timely manner in conjunction with functional management. Fosters creative thinking, innovation, knowledge sharing and reasoned risk-taking.Ensures appropriate review and refinement of project plans by functional area management and staff.Clearly communicates project/program recommendations and decisions to various stakeholders within the team, functional areas, R&D, and commercial management.Appropriately disseminates feedback from governance bodies and the functions to the team and extended organization.Acts on appropriate feedback from worldwide project team stakeholders and functional management to optimize performance as worldwide project team core team member. Program/development strategy/direct line management and research matrix management - Clinical Affairs representative for worldwide project team.Daily interaction with Sr. Management in multiple cross-functional areas, including finance, R&D, and regulatory affairs. - Manages internal organization/department within larger Clinical organization in a cross-functional environment. - Responsible for setting direction, creating/managing budget, prioritization, staff management and development.Required Qualifications Education: Bachelors Degree in related field OR an equivalent combination of education and work experienceMinimum 10 years Related work experience in clinical research; preferred industry experience in medical device or pharma.IDE, risk management, and/or clinical evaluation experience required.Management experience in other clinical operations and/or regulatory affairs positions.Global experience preferred.What We OfferAt Abbott, you can have a good job that can grow into a great career. We offer:A fast-paced work environment where your safety is our priorityProduction areas that are clean, well-lit and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesApply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at on Facebook at and on X @AbbottNews.The base pay for this position is $127,300.00 - $254,700.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:Clinical Affairs / Statistics DIVISION:EP Electrophysiology LOCATION:United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS:United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza WORK SHIFT:Standard TRAVEL:Yes, 5 % of the Time MEDICAL SURVEILLANCE:No SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol:
Clinical Technologies Program Director
Posted 7 days ago
Job Viewed
Job Description
**Fairview is looking for a Clinical Technologies Program Director to join our team.**
**Job Summary:**
The Program Director, Clinical Technologies role is responsible for ensuring successful implementation of clinical technology solutions, optimization of hospital workflows with operations, and enhancing patient care through innovation including the ongoing maturation of these solutions. This role programmatically leads the planning, execution, and deployment of clinical hospital technology initiatives to shape the overall system strategy and direction for the portfolio.
This individual maintains strong vendor, IT, and operational partnerships to expedite nursing and other clinical teams' innovation portfolio of work. They will facilitate establishing and then maintain the schedule of and dependencies for implementations, optimizations, and strategic planning activities for complex clinical technology projects like nurse call, clinical communications, cardiac monitoring, and others. This leader coordinates across informatics, IT, and operations to ensure successful end-to-end deployment of clinical technology solutions, including the hardware, software, integrated systems, various endpoints, and clinical workflows. They also facilitate the conduction of risk assessments and evaluation of the adoption and utilization of various technologies and provide plans to mitigate issues with the goal of ensuring seamless execution and safe use.
This leader aligns with the program and various project sponsors to understand and translate business objectives into an accumulative series of program outcomes in the operating context of the business. Together with the program sponsor, this role facilitates program advancement through governance activities, identification of risks and realization of benefits, communication of program decisions, and change management activities.
This role must have the ability to look at the big picture, translate business objectives into an outcomes-based framework for action, have strong project management skills and be proficient fostering team culture and dynamics. Other important attributes of this leader are having the ability to negotiate through disputes, excellent communication skills, and the ability to guide, referee and integrate multiple projects and project managers involved in the program.
**Position Details:**
+ mobile position: onsite work required as needed
+ salaried role
**Responsibilities:**
+ Articulate the clinical technologies vision, program strategy, and execution plan in terms of program outcomes required to achieve the business objective. Clarify business impact of projects and program to various stakeholders.
+ Define clinical technologies program execution structure, including component projects, teams and methodologies, and project management requirements. Apply standards and guidelines to define, organize and oversee a clinical technologies program execution structure.
+ Plan and coordinate resources for approved clinical technology project activities across informatics functions (clinical technologies, EHR/HIT instructional design and support, design & optimization, and change management). Coordinate underlying projects to attain their combined benefits for the program.
+ Provide framework/roadmap to integrate component projects and efforts, including clinical technologies program milestones and target outcomes. Establish and oversee an inventory of supporting processes to advance the adoption and use of clinical technologies.
+ Coordinate with the Transformation Office, IT PMO, and clinical technologies program sponsor to manage organizational change related to program deliverables.
**Required Qualifications**
+ B.S./B.A. Bachelor's degree in business, technology or related field or an equivalent combination of experience, education, and training.
+ 5 years managing programs with at least 7-10 years managing large, complex projects with technology components.
+ Must have advanced knowledge of the healthcare industry and the intersection of clinical care and technology needs facing care teams and operations.
+ Proven experience in hospital technology deployments, project management, or healthcare IT including a familiarity with various project and program management tools and methodologies
+ Ability to drive change management and stakeholder engagement in complex healthcare environments.
+ Strong understanding of clinical workflows, EHR and other health information technology systems, infrastructure, data integration, and healthcare compliance standards (e.g., HIPAA, FDA).
+ Ability to and experience with creation of a roadmap of outcomes across projects, setting realistic and measurable goals and timelines, and tracking outcomes over time.
+ Exceptional leadership, communication, critical thinking, and problem-solving skills.
+ Demonstrated ability to consistently communicate the big picture and vision to all audiences.
+ Demonstrated ability to negotiate and resolve challenges efficiently and effectively.
**Preferred Qualifications**
+ Bachelors Degree in Nursing
+ M.A./M.S.
+ Doctorate
+ PgMP Project Management Certification
**Benefit Overview**
Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more! Please follow this link for additional information: Disclaimer**
The posted pay range is for a 40-hour workweek (1.0 FTE). The actual rate of pay offered within this range may depend on several factors, such as FTE, skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization values pay equity and considers the internal equity of our team when making any offer. Hiring at the maximum of the range is not typical. If your role is eligible for a sign-on bonus, the bonus program that is approved and in place at the time of offer, is what will be honored.
**EEO Statement**
EEO/Vet/Disabled: All qualified applicants will receive consideration without regard to any lawfully protected status
Director, Clinical Evidence Generation (REMOTE)
Posted 5 days ago
Job Viewed
Job Description
**Date:** Jul 11, 2025
**Location:** Minneapolis, MN, US
**Company:** Teleflex
**Expected Travel** : Up to 10%
**Requisition ID** :12145
**About Teleflex Incorporated**
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** .
**Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
**Position Summary**
*** REMOTE ROLE ***
Teleflex People Managers use Leadership, Clinical Acumen and Business Acumen to lead and develop their Clinical Medical Affairs team to consistently deliver high value results and capability. They must be well planned and organized situational leaders and decision makers who use data, compassion and accountability to develop a culture of teamwork and results.
The position of Director, Clinical Evidence Generation requires an experienced individual with demonstrated skill and experience scoping, developing and executing clinical trial and clinical outcomes projects of diverse design. As Director, the successful candidate will also bring a track record of building and managing diverse clinical research teams with competencies that include protocol design, site selection, contracting and management, consent and IRB interactions, site audit, patient safety, electronic data capture and management, and study analysis through publication of scientific publications and regulatory study reports. Experience and comfort with cross-functional oversight is vital; the successful candidate will work closely and constructively with business unit executive leadership to drive execution, with Medical Directors to ensure strategic alignment.
The Director of Clinical Evidence Generation (CEG) is responsible for all clinical evidence generation activities for the US, EU, and other markets for Interventional devices.
**Principal Responsibilities**
- Oversees implementation and management of clinical studies globally with responsibility for quality, timeliness and completeness of execution.
- Oversees creation and maintenance of study related documents including protocols, study manuals, binders, investigator's brochure, protocol, forms, and study reports ensuring quality, methodological rigor, timeliness and consistency of methods across the enterprise.
- Oversees contracting and drives collaboration with / productivity from external research partners, including Contract Research Organizations), Data Management Groups, Core Imaging and Biometric Laboratories, Biostatisticians, Data Safety and Monitoring committees, Event Adjudication committees, etc.
- Serves as a knowledgeable and experienced resource for Study Managers, driving consistency of approach to study execution, problem solving and study reporting.
- In partnership with Finance, drives financially sound execution of all projects and the overall functional budget.
- Ensure the team works with the Regulatory lead and Medical Director to create sound regulatory strategies
- Represents the Clinical Evidence Generation team during execution of acquired evidence generation team integration arising from Corporate Development (M&A) activities.
- Organization Capability - Proactively manages performance and team dynamics to ensure that a fair, professional and high-performance environment, aligned with company values is maintained. Develops individual and organizational capabilities to build bench strength while delivering results now and into the future.
- Customer Experience - Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of
professionalism, service and ethics in order to strengthen the Teleflex brand and relationship with our customers.
- Continuous Improvement - Demonstrates initiative and critical thinking to identify, prioritize both process and performance gaps. Develops solutions and leads the team to deliver improving results. Serves as a leader to exemplify continuous improvement thought processes and focus.
- Culture and Values - Exemplifies Teleflex values and ensures a fair, open and productive climate that is engaging, ethical and legally compliant. Leads team to work effectively across boundaries in a complex matrix environment.
- Ensure that study documents are done in collaboration with CRO (Contract Research Organizations), Data Management Group and Biostatistician
- Manage CROs as necessary
- Manages a team of clinical research resources
- Participate as a clinical representative on cross-functional project team for development of studies
- Leads, coordinates, authors, and reviews clinical filing documents
- Provide tactical management, administration and leadership in order to ensure that the project goals of time, cost and quality are met
- Performs other related duties as assigned.
**Education / Experience Requirements**
- Bachelor's degree in scientific, medical sciences, nursing, or biomedical engineering
- At least ten years of related work experience in clinical trials or outcomes research obtained in an industry-based organization.
- Prior working experience with FDA, Notified Bodies, TGA, other OUS clinical bodies
- Experience with both pre-approval and post-approval studies
- Demonstrated understanding and knowledge of Good Clinical Practice (GCP)
- HCP Engagement experience is a plus.
- Proficient in Microsoft Word, Excel, and PowerPoint required; Prezzi, Video editing, Articulate, SalesForce, VEEVA Vault or equivalent experience preferred.
**Specialized Skills / Other Requirements**
- Must possess excellent verbal and written communication skills.
- Detail-oriented with strong organizational skills.
- Strong work ethic and ability to operate independently.
- Strong people skills and a team player.
- Ability to multitask, maintain timelines, and meet deadlines.
- Ability to work in a fast-paced, changing environment.
- Ability to collaborate with a broad range of personalities.
- Ability to quickly resolve challenges.
- Proven ability to successfully interact with CROs, CRAs (Clinical Research Associates), IRBs (Institutional Review Boards), EC (Ethical Committee), and other clinical authorities.
- Ability to work under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines.
- Strong leadership skills and experience, a fully engaged, hands-on professional capable of working collaboratively and independently in a small-company environment.
**TRAVEL REQUIRED: up to 10%**
The pay range for this position at commencement of employment is expected to be between $185,000- $195,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-LM1
_At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._
_Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: or
_Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._
_© 2025 Teleflex Incorporated. All rights reserved._
Senior Director Clinical Account Management - Remote
Posted 10 days ago
Job Viewed
Job Description
**Job Posting Title**
Senior Director Clinical Account Management - Remote
**Job Description**
The Sr Director of Clinical Account Management is responsible for providing strategic and operational leadership to a team of account executives and is accountable for the satisfaction and retention of assigned clients. This position collaborates across functions to ensure strategic alignment and execution of Prime, and assigned client priorities.
**Responsibilities**
+ Provide strategic and operational leadership to the account executive function; serve as point of escalation and accountable leader for issue resolution across clients.
+ Establish processes and tracking methodologies to monitor performance against contracts and prevent repeat issues in the future; develop and document standard operating procedures, reporting requirements, other operational activities required to serve our clients in a consistent and efficient manner.
+ Collaborate with the cross functional teams throughout the organization and maintain direct relationships with clients, specifically with the senior leadership; develop a consultative, service-oriented partnership with the client in order to maximize client satisfaction, contract renewals and the adoption of new or expanded use of Prime's products and services; build and maintain relationships with key client stakeholders and provide and request routine feedback from client contacts, including information on the performance of the pharmacy program and the strategic account plan.
+ Identify, establish and maintain relationships with key cross-functional partners; collaborate with account leadership and business development to develop and implement Go-To-Market strategies and establish a regular communication cadence to monitor performance, create awareness of issues and drive process improvements across the enterprise.
+ Leads contract negotiations and pricing for new business and renewals with clients; participates in request for proposals; account leadership during project implementations.
+ Review and assign account executive's book of business and determine necessary alignment and structure to support retention and fulfillment of strategic plans.
+ Facilitate strategic discussions with clients regarding the status and performance of services provided and the identification and execution of growth and retention strategies; support the development and execution of consultant engagement strategies necessary to grow the market.
+ Manage budgets and revenue goals, staffing, performance and development, and consistently demonstrate Prime's leadership expectations during interactions with direct reports, cross functional and external stakeholders; provides support, training and coaching to team members; oversees resolution of employee relations issues; supports team by attending face-to-face meetings with customers as needed.
+ Other duties as assigned.
**Education & Experience**
+ Bachelor's degree in Business, Marketing, Finance, Healthcare Administration, PharmD, or related field, or equivalent combination of education and/or related work experience; HS diploma or GED is required.
+ 8 years of relevant client services experience in healthcare or pharmacy benefit management, preferably in Medicaid.
+ 5 years of leadership / people management experience.
+ Must be eligible to work in the United States without need for work visa or residency sponsorship.
**Additional Qualifications**
+ Thorough understanding of the PBM industry with subject matter expertise in one or more areas (pharmacy trend, Medicaid plan benefits, etc.).
+ Excellent interpersonal skills, with the ability to effectively facilitate meetings, resolve conflict, build consensus, establish rapport, collaborate, and influence effectively across departments, internally and externally, and at all levels within an organization.
+ Able to balance and prioritize compliance, business and other competing goals and risks, while still driving programs and initiatives to completion.
+ Strong organization and prioritization skills, strong attention to detail, and the ability to simultaneously lead multiple, complex projects and strategies, under pressure and strict timeframes.
+ Proven ability to establish a team culture, create a clear and compelling vision, build trust, inspire action, achieve team results, and develop people.
+ Proven ability to produce and establish strategic plans to deliver consultative guidance with results of successful client retention and product adoptions.
+ Strong ability to manage complex information to develop well-reasoned solutions that solve client's problems.
+ Ability to work effectively in a matrixed team environment; demonstrated leadership experience across departments and functions.
+ Ability to drive the identification of improvements opportunities and lead the implementation of process changes.
**Preferred Qualifications**
+ MBA or other advanced degree
**Physical Demands**
+ Ability to travel up to 30% of the time
+ Ability to work outside of standard business hours when needed, which may include holidays, nights and weekends
+ Constantly required to sit, use hands to handle or feel, talk and hear
+ Frequently required to reach with hands and arms
+ Occasionally required to stand, walk and stoop, kneel, and crouch
+ Occasionally required to lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
+ Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their job, and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures.
Potential pay for this position ranges from $143,000.00 - $243,000.00 based on experience and skills.
To review our Benefits, Incentives and Additional Compensation, visit our Benefits Page ( and click on the "Benefits at a glance" button for more detail.
_Prime Therapeutics LLC?is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to?race, color, religion, gender, sex (pregnancy, sexual orientation, and gender identity), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law? ?_
_We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law._
_Prime Therapeutics LLC is a Tobacco-Free Workplace employer._
Positions will be posted for a minimum of five consecutive workdays.
Prime Therapeutics' fast-paced and dynamic work environment is ideal for proactively addressing the constant changes in today's health care industry. Our employees are involved, empowered, and rewarded for their achievements. We value new ideas and work collaboratively to provide the highest quality of care and service to our members.
If you are looking to advance your career within a growing, team-oriented, award-winning company, apply to Prime Therapeutics today and start making a difference in people's lives.
Prime Therapeutics LLC?is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to?race, color, religion, gender, sex (pregnancy, sexual orientation, and gender identity), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law? ?
We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law.
Prime Therapeutics LLC is a Tobacco-Free Workplace employer.
If you are an applicant with a disability and need a reasonable accommodation for any part of the employment process, please contact Human Resources at 1. or email
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Utilization Management Medical Director, Clinical Performance - Remote
Posted 10 days ago
Job Viewed
Job Description
Looking for a chance to drive measurable and meaningful improvement in the use of evidence-based medicine, patient safety, practice variation and affordability? You can make a difference at UnitedHealth Group and our family of businesses in serving our Medicare, Medicaid and commercial members and plan sponsors. Be part of changing the way health care is delivered while working with a Fortune 4 industry leader.
We are currently seeking a Utilization Management Medical Director to join our Clinical Performance team. This team is responsible for conducting hospital and post-acute utilization reviews for the state of California. The Medical Directors work with groups of nurses and support staff to manage inpatient care utilization.
You'll enjoy the flexibility to work remotely * as you take on some tough challenges.
**Primary Responsibilities:**
+ Work to improve quality and promote evidence-based medicine
+ Provide information on quality and efficiency to doctors, patients and customers to inform care choices and drive improvement
+ Support initiatives that enhance quality throughout our national network
+ Ensure the right service is provided at the right time for each member
+ Work with medical director teams focusing on inpatient care management, clinical coverage review, member appeals clinical review, medical claim review and provider appeals clinical review
Success in this technology-heavy role requires exceptional leadership skills, the knowledge and confidence to make autonomous decisions and an ability to thrive in a production-driven setting.
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
**Required Qualifications:**
+ MD or DO degree
+ Active, unrestricted license
+ Current board certification in ABMS or AOA specialty
+ 5+ years of clinical practice experience post residency
+ Solid understanding of and concurrence with evidence-based medicine (EBM) and managed care principles
**Preferred Qualifications:**
+ Hands-on utilization and/or quality management experience
+ Project management or active project participation experience
+ Substantial experience in using electronic clinical systems
*All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy
Compensation for this specialty generally ranges from $269,500 to $425,500. Total cash compensation includes base pay and bonus and is based on several factors including but not limited to local labor markets, education, work experience and may increase over time based on productivity and performance in the role. We comply with all minimum wage laws as applicable. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives.
**Application Deadline:** This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
_UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations._
_UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment._
Medical Director-Clinical Advocacy and Support - Remote
Posted 10 days ago
Job Viewed
Job Description
Clinical Advocacy & Support has an unrelenting focus on the customer journey and ensuring we exceed expectations as we deliver clinical coverage and medical claims reviews. Our role is to empower providers and members with the tools and information needed to improve health outcomes, reduce variation in care, deliver seamless experience, and manage health care costs.
The Medical Director provides physician support to Enterprise Clinical Services operations, the organization responsible for the initial clinical review of service requests for Enterprise Clinical Services. The Medical Director collaborates with Enterprise Clinical Services leadership and staff to establish, implement, support, and maintain clinical and operational processes related to benefit coverage determinations, quality improvement and cost effectiveness of service for members. The Medical Director's activities primarily focus on the application of clinical knowledge in various utilization management activities with a focus on pre-service benefit and coverage determination or medical necessity (according to the benefit package), and on communication regarding this process with both network and non-network physicians, as well as other Enterprise Clinical Services.
The Medical Director collaborates with a multidisciplinary team and is actively involved in the management of medical benefits for all lines of business. The collaboration often involves the member's primary care provider or specialist physician. It is the primary responsibility of the medical director to ensure that the appropriate and most cost-effective quality medical care is provided to members.
You'll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough challenges.
**Primary Responsibilities:**
+ Conduct coverage reviews based on individual member plan benefits and national and proprietary coverage review policies, render coverage determinations
+ Document clinical review findings, actions, and outcomes in accordance with policies, and regulatory and accreditation requirements
+ Engage with requesting providers as needed in peer-to-peer discussions
+ Be knowledgeable in interpreting existing benefit language and policies in the process of clinical coverage reviews
+ Participate in daily clinical rounds as requested
+ Communicate and collaborate with network and non-network providers in pursuit of accurate and timely benefit determinations for plan participants while educating providers on benefit plans and medical policy
+ Communicate and collaborate with other internal partners
+ Call coverage rotation
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
**Required Qualifications:**
+ M.D or D.O.
+ Active unrestricted license to practice medicine
+ Board certification in an ABMS specialty
+ 5+ years of clinical practice experience after completing residency training
+ Sound understanding of Evidence Based Medicine (EBM)
+ Proven solid PC skills, specifically using MS Word, Outlook, and Excel
+ Ability to participate in call coverage rotation
**Preferred Qualifications:**
+ Licensed in AZ, CA, MA, MN or TX
+ Board certified in family medicine or internal medicine
+ Experience in utilization and clinical coverage review
+ Proven excellent oral, written, and interpersonal communication skills, facilitation skills
+ Proven data analysis and interpretation aptitude
+ Proven innovative problem-solving skills
+ Proven excellent presentation skills for both clinical and non-clinical audiences
*All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy
Compensation for this specialty generally ranges from $238,000 to $357,500. Total cash compensation includes base pay and bonus and is based on several factors including but not limited to local labor markets, education, work experience and may increase over time based on productivity and performance in the role. We comply with all minimum wage laws as applicable. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives.
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
_UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations._
_UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment._
Senior Director, Global Clinical Development CNS
Posted 10 days ago
Job Viewed
Job Description
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
**Key Job Responsibilities**
+ Conceives, implements, and analyzes drug development programs, including:
+ Understanding pharmacology of drugs and unmet medical needs.
+ Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
+ Working with experts and consultants in the field to refine a clinical development strategy.
+ Designing clinical trials for the purpose of meeting specific objectives.
+ Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
+ Implements clinical development programs, including:
+ Co-authoring global clinical development plans with all practical elements.
+ Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
+ Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
+ Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
+ Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
+ Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
+ Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
+ Partners with internal decision makers to evaluate critical decision points.
+ Acts as a signatory for the medical monitoring team.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
+ Participates in NDA development, submission and defense.
+ Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
+ Mentors junior team members.
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in leading a successful regulatory filing.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
**Physical Demands and Work Environment**
Travel (approximately 30 **%** )
See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
**Company benefits** : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.