57 Clinical Development Director jobs in Elgin
Account Director, RWE Clinical Trials - Remote
Posted 4 days ago
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**Job Summary:**
Walgreens RWE Real World Evidence Clinical Trials is seeking an Account Director, RWE Clinical Trials with proven business development, client management, and stakeholder management skills to drive the success of the Walgreens RWE Clinicals Trials business segment. This position offers a unique entrepreneurial experience for a candidate who has been part of a team with demonstrated success in winning new clients, and who understands life sciences and associated market and business issues in Health Economics and Outcomes Research HEOR, Market Access and RWE.
The Account Director is responsible for the overall satisfaction and client management activities within a group of assigned clients. This role requires consultative, proactive sales activities directed at decision makers and decision influencers at existing and new client contacts. Proactively find and qualify opportunities including defining the solutions and recommending pricing structures to meet strategic goals. Serve as the primary contact until project Kick Off KO, then coordinates with the relevant business areas to ensure a successful implementation.
**Job Responsibilities:**
+ Client account and relationship management
+ Responsible for achieving budgeted sales within the assigned client accounts
+ Client account development to drive new business opportunities across the verticals of RWE Clinical Trials business e.g patient recruitment, Decentralized Clinical Trials DCT, HEOR and epidemiological studies, post marketing studies
+ Drive client account strategy and development through strategic and tactical account planning in partnership with the scientific research delivery teams
+ Work in collaboration with sales operations, finance, and other internal support functions to drive and close business and achieve sales authorization targets
+ This role requires consultative, proactive sales activities directed at decision makers and decision influencers at existing and new client contacts
+ Proactively find and qualify opportunities including defining the solutions and recommending pricing structures to meet strategic goals
+ Serve as the primary contact until project KO, then coordinate with relevant business areas to ensure a successful implementation
+ Lead and help deliver the response to Requests for Proposals RFPs during the proposal process with the proposal team and deliver in a timely fashion to clients
+ Coordinate Bid Defense strategy, ensuring targeted offering aligns with client objectives
+ Lead efforts to close a potential client for a clinical trial as part of the target sales targets
+ Responsible for assigned client account and identify opportunities within existing customers to increase account penetration
+ Provide a collaborative customer facing, problem solving environment with Sales, Marketing, Operations, and systems with the vision of enhancing Walgreens clinical trials market leadership.
**About Walgreens**
Founded in 1901, Walgreens ( has a storied heritage of caring for communities for generations, and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients' care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
The actual salary an employee can expect to receive, $102000 to $277000 plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits More Company information is available at .
"Walgreens is an equal opportunity employer".
**Job ID:** 1524471BR
**Title:** Account Director, RWE Clinical Trials - Remote
**Company Indicator:** Walgreens
**Employment Type:**
**Job Function:** Business Development/Planning
**Full Store Address:** 108 WILMOT ROAD,DEERFIELD,IL 60015
**Full District Office Address:** 108 WILMOT ROAD,DEERFIELD,IL,60015-05108-0001-Y
**External Basic Qualifications:**
+ Bachelors degree and at least 6 years of experience in direct or indirect (such as clinical trials, RWE, life sciences) client account management responsibilities OR High School GED and at least 9 years of experience in direct or indirect (such as clinical trials, RWE, life sciences) client account management responsibilities
+ Scientific, sales and marketing background with concentration in pharmaceutical biotech area
+ Proven track record of developing mid and high level business contacts
+ Excellent interpersonal skills in order to manage and fully integrate with Operations, Finance, and Marketing, and follow up to expand relationships and business opportunities
+ A solid understanding of RWE trends and needs
+ Demonstrated experience in identifying and developing sales leads, making professional presentations managing the sales process through close, and handling all aspects of contract negotiations
+ Understanding of sales automation systems and Microsoft Office programs
+ Experience collaborating with internal or external resources to develop strategies that meet department goals within budget and established timelines
+ At least 2 years of experience contributing to financial decisions in the workplace.
+ At least 3 years of direct leadership, indirect leadership and cross functional team leadership
+ Willing to travel up to 10% of the time for business purposes within state and out of state
**Preferred Qualifications:**
+ Masters degree or MBA
We will consider employment of qualified applicants with arrest and conviction records.
**Shift:**
**Store:**
Research and Clinical Trials Financial Planning Analyst
Posted 4 days ago
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Job Description
Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Rush Univ Cncr Center-Res Recr
**Work Type:** Full Time (Total FTE between 0.9 and 1.0)
**Shift:** Shift 1
**Work Schedule:** 8 Hr (8:00:00 AM - 5:00:00 PM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page ( Range:** $29.36 - $47.79 per hour
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush's anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
**Summary:**
Rush University Medical Center is searching for an experienced finance- and accounting-oriented individual to support budgeting in a cancer clinical trials research environment. The Financial Planning Analyst will perform various financial or budget analyses, accounting and accounts receivable, financial reporting, preparing standard and/or ad hoc reports, and providing other support for departmental processes such as developing clinical trials budgets, negotiating clinical trials budgets with external entities, management and tracking of chargeback methodologies, and revenue/expense variance analyses. This detail-oriented individual will serve as a liaison between the Principal Investigator, Coverage Analysts, Investigator/or Sponsor, and the Director of Cancer Clinical Trials. This position requires a working knowledge and understanding of complex budgets and coordination of information between the informed consent, coverage analysis, internal and external budget reports and research contracts. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
**Required Job Qualifications:**
+ Bachelor's Degree in business (accounting or finance).
+ Four years of experience in financial analysis or financial planning or the equivalent combination of education, training and experience where the required knowledge skills and abilities have been acquired.
+ Ability to conduct financial analysis and produce financial statements and report.
+ Familiar with standard concepts, practices, and procedures needed to perform job duties.
+ Familiar with clinical trials.
+ Possesses a high level of attention to detail.
+ Excellent verbal and written communication skills, with ability to interface at all levels throughout the organization.
+ Highly motivated with good organizational skills.
+ Able to prioritize and meet multiple deadlines; works well under pressure.
+ Self-starter with ability to work under minimal supervision.
+ Proficient in MS Office Products with advanced knowledge of Excel and Access; ability to work with and be proficient in stand-alone system applications.
**Preferred Job Qualifications:**
+ Experience in a large healthcare system, healthcare research system, university, or similar environment.
+ Experience with budgeting and accounts receivable for research and clinical trials
+ Experience with clinical trials and/or research environments
+ Experience working on the financial side of research administration.
**Responsibilities:**
1. **Preparation of management reports as assigned. These include:** daily revenue reports, monthly revenue/expense variances, budget summaries, long-term plan reports, capital planning/monitoring reports, clinical trials fund accounting, invoice accounting, etc.
2. Coordinate flow of financial data including collection, maintenance and updating of data to support the development, analyses and monitoring of various departmental processes or functions. Perform required financial analyses utilizing this data as assigned.
3. Support departmental leadership in the process of developing the annual operating/capital budget, the long-term financial plan, the periodic reforecast, etc.
4. Create, manage, and track chargeback methodologies for functions related to clinical trials and interactions with other entities throughout the institution.
5. Create, manage, and oversee budgeting standards for all clinical trials. Interact with Research Affairs staff to assist in clinical trials creation and negotiation. Give updates and reports to physicians, leadership, committees, and staff as appropriate.
6. Assist with coverage analysis, billing/accounts receivable, accounts payable, and collections as it relates to clinical trials. Act as the liaison to the Research Revenue Cycle team. Assist with patient insurance questions and concerns as it relates to clinical trials.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
**Position** Research and Clinical Trials Financial Planning Analyst
**Location** US:IL:Chicago
**Req ID** 16656
Quality Assurance Manager, RWE Clinical Trials (Remote)
Posted 4 days ago
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Job Description
**Job Summary:**
The Quality Assurance Manager is responsible for the operations and maintenance of the Quality Management System (QMS) under oversight of the Sr. Director of Quality Assurance. The Quality Assurance function serves to ensure compliance with the US FDA requirements as well as internal quality systems requirements. The Quality Assurance function also has oversight of internal and sponsor audits as well as regulatory inspections, compliance and regulatory support initiatives. This position plays a crucial role in Clinical Trials program wide culture of quality.
**Job Responsibilities:**
+ Accountable for daily operations to maintain Quality standards and project timelines.
+ Demonstrate proficiency in formal quality management systems (QMS) deployment.
+ Lead QMS initiatives (e.g., Vendor Management Process, CAPA)
+ Manage Clinical Trials Standard Operating Procedure development, review and maintenance.
+ Maintain an open line of communication with the stakeholders or project deliverables.
+ Identify and escalate any critical or major findings or trends to the Sr. Director of Quality Assurance.
+ Provide guidance to staff in resolving findings and implementing processes, including root case analysis, implementation, and evaluation of CAPA plans.
+ Work closely with leadership to close identified gaps and ensure continuous process improvement in collaboration with the broader Quality Management function (i.e., Quality Control, Quality Assurance, and Compliance)
+ Develop internal and external audits/inspections plans and conduct audits.
+ Ensure conduct of initial and ongoing study risk assessments and the development of strategies for approaching identified risks.
+ Contribute to development and implementation of an integrated Quality Management Plan for each study, as needed.
+ Independently review reports and documentation generated by the sponsor/CRO for each ensure all findings are resolved.
+ Support the Sr. Director of Quality Assurance with implementation of a comprehensive staff training program, including content delivery and documentation compliance with all required training.
About Walgreens
Founded in 1901, Walgreens ( has a storied heritage of caring for communities for generations, and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients' care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits More Company information is available at ID:** 1627429BR
**Title:** Quality Assurance Manager, RWE Clinical Trials (Remote)
**Company Indicator:** Walgreens Boots Alliance
**Employment Type:**
**Job Function:** Business Development/Planning
**Full Store Address:** 108 WILMOT ROAD,DEERFIELD,IL 60015
**Full District Office Address:** 108 WILMOT ROAD,DEERFIELD,IL,60015-05108-0001-Y
**External Basic Qualifications:**
+ Bachelor's degree and 4 years of experience in Pharma/Clinical Quality Management OR High School/GED and 7 years of experience in Pharma/Clinical Quality Management.
+ Deep understanding of the drug/device development process including new clinical trials models.
+ Exceptional working knowledge of ICH GCP, US CFR, and HIPAA regulations.
+ Experience working independently and making informed decisions related to clinical trial quality.
+ Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail.
+ Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities.
+ At least 2 years of experience contributing to financial decisions in the workplace.
+ At least 2 years of direct leadership, indirect leadership and/or cross functional team leadership.
+ Willing to travel up to/at least 25% of the time for business purposes (within state and out of state)
**Preferred Qualifications:**
+ Quality Management System and continuous improvement experience.
+ Decentralized/hybrid clinical trials experience.
+ Expertise of modern clinical trial site technologies (e.g., eReg, eSource, eConsent).
+ Tech-savvy with the experience applying new systems to everyday tasks.
The actual salary an employee can expect to receive, $95,600-$244,800, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits More Company information is available at .
We will consider employment of qualified applicants with arrest and conviction records.
**Shift:**
**Store:**
Patient Recruitment & Retention Manager, RWE Clinical Trials (Remote)
Posted 4 days ago
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Job Description
**Job Summary:**
The Patient Recruitment & Retention Manager within Walgreens RWE Clinical Trials business will be responsible to oversee and manage patient recruitment and retention programs with biopharmaceutical companies (Sponsor) including participating in pre-sales activities, contracting, and ensuring the recruitment program meets contractual requirements in accordance with SOPs, policies, and practices. The role of the Patient Recruitment & Retention Manager is focused on recruitment project delivery, productivity, and quality to ensure strong customer and patient satisfaction for outreach and retention campaigns.
**Job Responsibilities:**
+ Lead and coordinates project activities and leads completion of deliverables in alignment with overall recruitment program strategy considering impact to risks/risk mitigation, budget, effort estimates and schedule
+ Serve as the point of contact for the Sponsor and other functional team members for the assigned recruitment project
+ Participate in bid defense preparations. Lead bid defense presentations in partnership with the Business development team
+ Lead activities across numerous functions to meet the objectives of multiple recruitment programs including scope, budget, and schedule
+ Establish and maintain project documentation and procedures
+ Develop risk mitigation plans including appropriate communication and escalation plans to mitigate risk
+ Collaborates closely with other core team leaders within the Clinical Trials business
+ Demonstrates the ability to proactively identify solutions to improve existing business processes
+ Understands and maintains compliance with internal and external privacy and legal
+ Manage the recruitment project finances in accordance with the customer contract and the budget; Work closely with the Sr. Manager and Director of Patient Recruitment and Retention, RWE Clinical Trials and Finance
+ Identify changes in scope and manage the change control process, as necessary
**About Walgreens**
Founded in 1901, Walgreens ( has a storied heritage of caring for communities for generations and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits More Company information is available at LI-AJ1
**Job ID:** 1630204BR
**Title:** Patient Recruitment & Retention Manager, RWE Clinical Trials (Remote)
**Company Indicator:** Walgreens Boots Alliance
**Employment Type:**
**Job Function:** Business Development/Planning
**Full Store Address:** 108 WILMOT ROAD,DEERFIELD,IL 60015
**Full District Office Address:** 108 WILMOT ROAD,DEERFIELD,IL,60015-05108-0001-Y
**External Basic Qualifications:**
+ Bachelor's Degree and at least 2 years of experience in patient recruitment and retention, clinical research and project management experience Or High School Diploma and at least 5 years of experience in patient recruitment and retention, clinical research and project management experience
+ Bachelor's degree in Life Sciences, Marketing, or related field and at least 2 years of experience working in patient recruitment and retention.
+ Experience leading patient recruitment and retention strategies while collaborating with others to deliver results to meet timeline, metrics, and budget.
+ Knowledge of the use of RWE for patient cohort definitions
+ Knowledge of outreach campaign management systems and technology enabled solutions (EMR/Health Record Experience, Hybrid trials) with respect to use in patient recruitment.
+ Knowledge of clinical trials, and experience with applicable clinical research regulatory requirements (ie. GCP and ICH guidelines)
+ Experience utilizing a results-oriented approach to delivery
+ Knowledge of project finances including experience managing, contractual obligations and implications
+ Experience organizing resources needed to complete tasks, set objectives, and provide clear direction to other team members
+ Experience recruiting patients with diverse race, ethnic and socioeconomic backgrounds
+ At least 1 year of direct leadership, indirect leadership and/or cross-functional team leadership.
+ Willing to travel up to/at least 15% of the time for business purposes (within state and out of state).
**Preferred Qualifications:**
+ At least 4 years of patient recruitment and retention experience within a biopharmaceutical company, CRO, patient recruitment vendor or similar organization
+ Experience recruiting patients locally and/or in-person within a local community.
The actual salary an employee can expect to receive, $77,100- 197,300, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits More Company information is available at .
We will consider employment of qualified applicants with arrest and conviction records.
**Shift:**
**Store:**
Director, Clinical QA Management RWE Clinical Trials - Remote
Posted 4 days ago
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Job Description
**Job Summary**
The Director, Clinical Quality Assurance Management for the RWE Clinical Trial business will be responsible for the management and operational oversight of the quality activities for the broader business and clinical trial site level to ensure Walgreens conducts is trials to the highest quality and regulatory obligations and enhances performance through continuous improvements. This will also include the need to proactively assess and identify risks, tackle unplanned deviations, corrective/preventative actions, and proactive monitor and trending of quality issues to ensure business is performing to Good Clinical Practice (GCP) standards.
This role will also be responsible to lead Quality Assurance (QA) professionals.
**Job Responsibilities**
+ Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate.
+ Identify appropriate staff SOP training requirements and maintain oversight of training to ensure all Walgreens clinical trials staff are trained on SOPs Ensure staff SOP training requirements are achieved for QA and
+ Implement and maintain a Quality Management System (QMS) in line with the Corporate QMS and take the lead in presenting it to internal stakeholders, pharmaceutical companies and other funding partners.
+ Build, manage, lead and motivate a QA team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximized.
+ Ensure quality and operational compliance; act as a subject matter expert for quality investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs.
+ Develop and implement a risk-based and flexible approach to QA in compliance with applicable regulatory requirements.
+ Generate and analyze weekly, monthly and quarterly metrics to track KPIs
+ Work with Operations team to implement, review and maintain tracking of incidents within the clinical trials, advising on CAPAs to be implemented and ensure completion in a timely manner.
+ Lead the Audit Program management process, including assessment of internal and external (outsourced) operations, and active audit and regulatory inspections.
+ Partner with functional areas in study design, data collection, and analysis, and reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring.
**About Walgreens**
Founded in 1901, Walgreens ( has a storied heritage of caring for communities for generations and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients' care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
#LI-TO1
**Job ID:** 1522740BR
**Title:** Director, Clinical QA Management RWE Clinical Trials - Remote
**Company Indicator:** Walgreens
**Employment Type:**
**Job Function:** Business Development/Planning
**Full Store Address:** 108 WILMOT ROAD,DEERFIELD,IL 60015
**Full District Office Address:** 108 WILMOT ROAD,DEERFIELD,IL,60015-05108-0001-Y
**External Basic Qualifications:**
+ Comprehensive, excellent understanding of GCP, CFR and ICH guidelines
+ Significant experience with managing clinical quality activities and in-depth knowledge of clinical operations.
+ Significant experience in with clinical trial site/process audits and regulatory inspections
+ Experience in line management of employees.
+ Experience translating Pharma/Sponsor needs for innovation and creative approaches to quality management.
+ Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team.
+ Excellent verbal and written communication and presentation skills.
+ Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a start-up environment.
+ At least 2 years of experience contributing to financial decisions in the workplace.
+ At least 3 years of direct leadership, indirect leadership and/or cross- functional team leadership.
+ Willing to travel up to 15% of the time for business purposes (within state and out of state)
**Preferred Qualifications:** We will consider employment of qualified applicants with arrest and conviction records.
An employee in this position can expect a salary rate between $102,000 and $277,600 plus bonus pursuant to the terms of any bonus plan if applicable. The actual salary will depend on experience, seniority, geographic location, and other factors permitted by law. This job posting will remain open for a minimum of two weeks from the job posting date. To review benefits, please click here jobs.walgreens.com/benefits . If you are applying on a job board or unable to click on the link, please copy and paste this URL into your browser jobs.walgreens.com/benefits.
**Shift:**
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Executive Medical Director, Clinical Development
Posted today
Job Viewed
Job Description
Executive Medical Director, Clinical Development
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1994
Employees
51-200
Categories
- Manufacturing
- Pharmaceuticals
- Medicine
- Chemical Products
- Biotechnology
About the Role
The Company is in search of a Vice President / Executive Medical Director to spearhead the clinical development of its neuromuscular asset. The successful candidate will be the primary clinical development leader, engaging in both internal and external interactions with key stakeholders. This role demands a deep understanding of the science behind the pipeline, excellent leadership skills, and a commitment to the development of new treatments for patients. Responsibilities include serving as the lead physician in all clinical development activities, collaborating with cross-functional teams to create and revise clinical development plans, and leading the design of clinical protocols. The role also involves overseeing the medical monitor, ensuring the continuous evaluation of the drug's safety profile, and participating in interactions with global health authorities. Applicants must have an MD or DO, with board certification/eligibility in neuromuscular and/or rare disease highly desired. A minimum of 7 years of experience in the pharmaceutical or biotech industry, including leading late-stage clinical trials, is required. The ideal candidate will have a proven track record in global clinical research, interaction with health authorities, and successful experience in the end-of-phase 2 and/or NDA/BLA processes. The role calls for an individual with a strong background in clinical trial design, methodology, and statistical concepts, as well as a history of success in leading cross-functional product teams. Outstanding leadership, problem-solving, organizational, and communication skills are essential, as is the ability to travel and work in a highly collaborative, multidisciplinary team setting.
Hiring Manager Title
CMO
Travel Percent
20%
Functions
- Medical Care/Hospital Administration
- Non-Profit Management
Associate Scientific Director, Clinical Development - Hematology
Posted today
Job Viewed
Job Description
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: •With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff. •Has responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables. •Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. •May be asked to contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members. •Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies. •Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. •Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions. •Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Qualifications •Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) required. •Ability to provide input and direction to clinical research with appropriate supervision. •Strong desire to collaborate in a cross-functional setting. •Clinical trial experience in the pharmaceutical industry, academia, or equivalent is required. •Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable. •Ability to interact externally and internally to support global scientific and business strategy. •Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr
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Senior Executive Medical Director, Clinical Development
Posted 7 days ago
Job Viewed
Job Description
Senior Executive Medical Director, Clinical Development
About the Company
Join an innovative biopharmaceutical company dedicated to transforming the future of medicine.
Industry
Pharmaceuticals
Type
Public Company
Founded
1994
Employees
51-200
Categories
- Manufacturing
- Pharmaceuticals
- Medicine
- Chemical Products
- Biotechnology
About the Role
We are seeking a dynamic and experienced Senior Executive Medical Director to lead the clinical development of our cutting-edge neuromuscular asset. This pivotal role will have you at the forefront of clinical innovation, engaging with both internal teams and external stakeholders to drive our mission of delivering new treatments to patients. As the primary clinical development leader, you will oversee all clinical development activities, ensuring alignment with our strategic vision.
Your responsibilities will include:
- Serving as the lead physician and driving all aspects of clinical development.
- Collaborating closely with cross-functional teams to create, implement, and revise comprehensive clinical development plans.
- Leading the design of innovative clinical protocols.
- Overseeing the medical monitor to maintain a continuous evaluation of the drug's safety profile.
- Engaging with global health authorities to advocate for our clinical programs.
To be successful in this role, you should possess an MD or DO, alongside board certification or eligibility in neuromuscular conditions or rare diseases. A minimum of 7 years of relevant experience within the pharmaceutical or biotech industry is essential, particularly in leading late-stage clinical trials. You will have a track record of excellence in global clinical research, successful interactions with health authorities, and experience navigating the end-of-phase 2 and/or NDA/BLA processes.
The ideal candidate will demonstrate robust clinical trial design expertise, a clear understanding of methodology, and statistical concepts, with a history of effectively leading cross-functional teams. Exceptional leadership, problem-solving, organizational, and communication skills are crucial, as well as the willingness to travel and work in a collaborative, multidisciplinary environment.
Hiring Manager Title
CMO
Travel Percent
20%
Functions
- Medical Care/Hospital Administration
- Non-Profit Management
Associate Medical Director / Medical Director, Clinical Development
Posted today
Job Viewed
Job Description
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
What You'll Do:
We are looking for an Associate Medical Director/Medical Director, Clinical Development to join the Medical Science team at Tempus. This position will report to the Vice President, Clinical Development and will be based in the Tempus hub in Chicago, IL; New York, NY; or Redwood, CA.
Responsibilities Include:
- Drive clinical development plans for new precision medicine products, such as genomic assays and algorithmic diagnostics, through the whole lifecycle including clinical validation and clinical utility studies as well as post-market data review across different oncology indications
- Provide medical expertise and subspecialty clinical context for development and delivery
- Design and conduct studies, including documentation and data analyses
- Lead and collaborate with multidisciplinary teams in a matrix environment including biostatistics, R&D scientists, bioinformatics, operations, legal, business development, scientific communications, marketing, regulatory, and more
- Deliver clinical/scientific presentations and publications for medical audiences, including conferences
- Engage in collaborations with external clinical research centers and investigators
Required Qualifications:
- MD degree or equivalent, advanced training in Oncology preferred
- 5 years of clinical research experience required. Including but not limited to the biotechnology/pharmaceutical, clinical research organization, or primary investigator academic research settings
- Ability to work collaboratively in a team environment and lead cross-functional teams
- Strong analytical thinking, strategic thinking, implementation, and research skills
- Goal oriented, self-motivated, and driven to make a positive impact in healthcare
- Thrive in a fast-paced environment with the ability to adapt to changing priorities
- Experience with site engagement and operations in clinical research settings
- Strong communication skills, including oral and written communication skills
- Able to work well with external investigators
- Innovative thinker regarding clinical development and study execution
Preferred Skillsets:
- Understanding of or interest in genomics, molecular diagnostics, data, artificial intelligence, machine learning, bioinformatics/clinical informatics, real world evidence, clinical innovation or novel technologies in drug discovery and clinical development
- Previous experience with:
- Leading teams including planning, timely organization of components of the clinical development plan, clinical trial development, and crossfunctional work to achieve successful study execution
- Precision medicine, drug development, medical devices or diagnostics development
- Medical monitoring, study design and documents, trial oversight and conduct
- Good Clinical Practice and other regulations governing research, health authority responses and interactions
- Clinical practice guidelines, device and/or drug approvals, label expansions
- Planning and management of investigator meetings, advisory boards, and other scientific committees
- Clinical partnerships, consulting, and/or client-facing experience
- Peer-reviewed publications
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Clinical Research Manager
Posted 5 days ago
Job Viewed
Job Description
Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.
Location: Streeterville, Chicago, IL
Time Type: Full time
Job Description
The Manager, Clinical Research role provides leadership, strategic management, and administration for clinical and translational research. Supervises and manages the research staff in the divisional unit. Serves as the key operational interface between the funding agencies, Stanley Manne Children's Research Institute (SMCRI), research team, and principal investigators. Works with a multidisciplinary team of physicians and staff to maintain an environment that encourages customer service and promotes employee satisfaction. Models and supports the principles of good clinical practice with the research team.
Essential Job Functions:
- Serves as a clinical research leader to research and clinical staff both internal & externally regarding study procedures and processes, monitoring team workflow, and advises on implementation of complex protocols and projects.
- Has expert knowledge of all functions a research coordinator performs and provides leadership management of education & execution of those responsibilities.
- Establishes strategic plans, policies, and procedures to assist the research program in fulfilling its research goals and objectives.
- Disseminates critical clinical and operational updates and information from the hospital and research institute to research teams in real-time.
- Assists principal investigators to identify new federal, foundation, and industry funding opportunities, prepare applications for funding, and manages existing grants and contracts. Implements and interprets research and financial policies and procedures in conjunction with the Research Business Operations (RBO) offices and Office of Clinical and Community Trials (OCCT).
- Provides oversight and accuracy of all charges to applicable grant/gift accounts including salary and miscellaneous expenses.
- Reviews and coordinates time and effort reporting for faculty and clinical research staff. Responsible for pre-award and post-award activities with principal investigators relating to sponsored research grant proposals and projects in conjunction with the Research Business Operations (RBO) offices.
- Works with the Research Business Operations (RBO) offices and Office of Clinical and Community Trials (OCCT) to facilitate contract negotiations and execution, to ensure proper accrual tracking, and to provide additional information as needed for timely financial reconciliation, management, and reporting.
- In conjunction with the SMCRI central offices; monitors study funds, reconciling faculty and staff salaries, subcontractor invoices, incoming sponsor payments, cost transfers and other allocable expenses ensuring financial compliance.
- Reviews and coordinates time and effort reporting for faculty and clinical research staff.
- Works with other departments/disciplines/ancillary support services to coordinate all aspects of research projects. Ensure up-to-date document management and participant tracking in applicable Lurie systems (study intake, eRegulatory, eRA, CTMS, Epic, etc).
- Prepares and submits regulatory documents to the government and/or sponsor and provides oversight to other research staff responsible.
- Prepares for and leads audits and participates in discussion with regulatory authorities.
- Partners with the Office of Research Integrity and Compliance (ORIC) to ensure compliant research execution. Leads or participates in division research meetings and sponsor study meetings/teleconferences.
- Promotes the research program by participating in local and national meetings and works with faculty to report results via publications and presentations.
- Recruits and supervises research personnel, including training and mentoring research staff and providing opportunities for staff education, development, and professional growth. The authority to hire, separate, promote, demote, write, and administer performance evaluations.
Knowledge, Skills and Abilities:
- Bachelor's degree and five or more years research experience required. Master's degree and/or relevant research certification preferred.
- Expert knowledge of FDA and GCP Guidelines.
- Excellent organizational skills with ability to manage simultaneous project plans and personnel.
- Strong analytical ability: ability to understand and interpret financial data; solid quantitative and qualitative skills.
- Ability to communicate effectively in a leadership role with clinical, business and administrative staff. Ability to work with a team. Strong customer service skills.
- Exceptional verbal and written communications skills.
Education: Bachelor's Degree (Required)
Pay Range: $83,200.00-$137,280.00 Salary
At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter.
Benefit Statement: For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance; Employer paid group term life and disability; Employer contribution toward Health Savings Account; Flexible Spending Accounts; Paid Time Off (PTO), Paid Holidays and Paid Parental Leave; 403(b) with a 5% employer match; Various voluntary benefits including Supplemental Life, AD&D and Disability coverage; Critical Illness, Accident and Hospital Indemnity coverage; Tuition assistance; Student loan servicing and support; Adoption benefits; Backup Childcare and Eldercare; Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members; Discount on services at Lurie Children's facilities; Discount purchasing program.
There's a Place for You with Us
At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care.
Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.
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