60 Clinical Development Director jobs in Conley

Position Summary

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 ( ) .

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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.

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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.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.Essential Responsibilities and Duties:Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.Organizes research information for clinical trials.Observes subjects and assists with data analysis and reporting.Schedules the collection of data.Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.Monitors, and reports research data to maintain quality and compliance.Performs administrative and regulatory duties related to the study as appropriate.Participates in other protocol development activities.Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)Educates potential participants and caregivers on protocol specific details and expectations.Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes.Assists the CTM in planning, creating processes, trainings and development of staff.Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.Education/Experience/Skills:Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position.High school graduate or equivalent; Bachelors Degree, preferredCCRC certification preferred2-3 years of experience in the medical field, preferredKnowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.Strong leadership and mentorship skills.Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.Works independently as well as functioning as part of a team.Must be able to effectively communicate verbally and in writing.Working Conditions Indoor, Office environment.Shift work, depending on location.Essential physical requirements include sitting, typing, standing, and walking.Lightly active position, occasional lifting of up to 20 pounds.Reporting to work, as scheduled, is essential.Overnight travel may be required for training and/or investigative meetings.CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Working On-site Schedule: 20 hours per week.

Responsibilities:

• Phlebotomy is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role.
• Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including spirometry, and vital signs.
• Coordinate clinical research studies conducted by a supervising principal investigator.
• Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research.
• Safeguard the well-being of the subjects and ensure and maintain high standards:
• Maintain a safe environment in accordance with Health and Safety policies.
• Act as a volunteer advocate.
• Address volunteer and visitor concerns proactively and take remedial action as required.
• Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer.
• Report any deviation from normal practice to senior staff.

Support Study Conduct By:

• Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems.
• Participating in project meetings with the project team as needed.
• Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents.
• Planning logistical activity for procedures as per protocol.
• Generating volunteer instructions.
• Identifying and obtaining required supplies and equipment.
• Preparing and delivering study-specific training materials, documents, and records.
• Troubleshooting study issues.
• Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards.
• Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness.
• Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria.
• Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits.
• Responsible for the correct administration and custody of study drug according to site standard operating procedures.
• Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
• Cooperating with the study monitor and reserving sufficient time for questions during monitoring.
• Following ICH GCP guidelines with regards to all study and patient activities.

Qualifications:

• Equivalent education and experience - High School Diploma and 1 years' relevant work experience in clinical research
• At least 1 year experience working in a clinical research setting preferred.
• Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies.
• Working knowledge of clinical trials.
• Working knowledge of the principles of Good Clinical Practices (GCP).
• In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules.
• Skill in carrying out required clinical procedures.
• Working knowledge of medical terminology.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients.

Please note, this position is not eligible for sponsorship.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Clinical Research Coordinator Work Set-Up: Working On-site. Schedule: 20 hours per week. Responsibilities:Phlebotomy is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role. Perform a variety of Clinical Research, Research Coordinator, Clinical, Coordinator, Research, Volunteer, Technology

Job Details Job Location : CBO Office - Atlanta, GA Position Type : Full Time Education Level : 4 Year Degree Salary Range : Undisclosed Travel Percentage : As needed for business requirements. Job Category : Ancillary Services Description GENERAL SUMMARY OF DUTIES: The Clinical Research Director is responsible for the daily operations and overall success of United Digestive’s clinical research department. This includes oversight of central research functions, financial performance, quality assurance, and staff management across all research locations. The director ensures studies are adequately staffed, maintains and develops relationships with pharmaceutical sponsors and investigators, and supports the onboarding of new investigators. A thorough knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements is essential to this role. REPORTS TO: Director of Ancillary Services RESPONSIBILITIES: Duties include but are not limited to: Manages overall clinical research department staff, inclusive of clinical research coordinators, clinical research nurses, and any staff performing research functions including but not limited to patient recruiters, contract / budget specialists, regulatory specialists, and business development personnel Oversight of both Georgia and Florida research activities for United Digestive research department, with expected travel to research sites as necessary Responsible for overall quality of clinical research department, including adherence to ICH-GCP, regulatory requirements, and department SOPs Oversees clinical research department finances working with United Digestive leadership to ensure department hits profitability targets Identifies, analyzes, and resolves daily workflow issues within departments including study-specific challenges Develops relationships with study sponsors and contract research organizations (CROs) to become a preferred site for research services on current and future studies Identifies, pursues, and evaluates potential new study opportunities for both profitability, viability (including proper resourcing), and alignment with investigator interest and company goals Maintains strong relationships with investigators at United Digestive and ensures that research staff is fully supported operationally to ensure the success of research projects Develop new relationships with United Digestive physicians to support the growth of the research program at United Digestive while facilitating referral program Encourages enrollment success by partnering with research staff and utilizing both internal and external recruitment strategies Supports study contracting and budgeting efforts for organizational approval, ensuring ancillary costs are covered and studies will be profitable for the department Works closely with UD finance team to ensure research finances are being appropriately tracked, invoiced, reconciled, and received Oversees the recruiting, hiring, training / development, and evaluation of all clinical research staff Maintains strong relationships and oversight of study sponsors throughout the entire clinical research process, including start up, ongoing monitoring visits, and close out Responsible for maintaining study regulatory compliance and proper site staff training including GCP, IATA, etc. Any other duties and special projects assigned by UD Leadership EDUCATION, SKILLS AND EXPERIENCE: Required: Bachelor’s degree in healthcare or related field 7+ years of clinical research experience, preferably at a clinical research site Must have a strong understanding of GCP guidelines and regulatory requirements Experience with clinical research CTMS platforms and workflows Computer literate, ability to operate Microsoft Office applications Preferred: Preferred experience with large healthcare systems Preferred experience with gastrointestinal or metabolic clinical research studies CORE SKILLS AT UNITED DIGESTIVE: Director of Clinical Research have or must be able to: Plan, prioritize, and complete multiple tasks effectively Work under pressure; assess, respond to, and communicate issues in a timely manner Strong problem-solving skills and ability to handle conflict resolution Maintain composure and set professional examples to staff and patients Communicate clearly and present detailed information to a multidisciplinary audience Interpret and apply clinical and non-clinical policies and procedures PHYSICAL/MENTAL/ENVIRONMENTAL DEMANDS Requires sitting and standing associated with a normal office environment; travel as business needs require DRUG FREE WORKPLACE United Digestive is a drug free workplace. All offers of employment are contingent upon passing a pre-employment drug screening. EQUAL OPPORTUNITY EMPLOYER United Digestive is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, gender, color or national origin in its employment practices. Qualifications #J-18808-Ljbffr

Clinical Research Physician / Principal Investigator Clinical Research Physician / Principal Investigator 2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Company Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Company Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Physician/ Principal Investigator at Wake Research, an M3 company. This is an on-site role. Job Description As a Clinical Research Physician, you will provide clinical mentorship and leadership for clinical development and clinical trials conduct within our organization. You will operate in a wide range of aspects in clinical and pharmaceutical medicine and with patients, health authorities, colleagues, and biopharmaceutical companies. Your role will be focused clinical trials, phase I to IV, where you will be responsible for assessing and following the safety of clinical trial participants and collaborate with the team with all aspects of clinical and scientific input and safety evaluation. Essential Duties And Responsibilities Provide clinical expertise into the conduct of clinical trials Build positive relationships and networks with internal and external medical professional and local opinion leaders Work closely with colleagues in other functions including, Regulatory Affairs, Clinical Operations and Patient Engagement Lead and provide an oversight to a team of researchers and clinical staff involved in conduct of clinical trials Be responsible for successful execution of research protocols according to FDA regulations and GCP guidelines Evaluate study volunteer’s eligibility for clinical trials Perform physical exams and assessments as required per research protocols Complete all industry-required training Assess study patient health through interviews and physical examinations Communicate information to patients regarding diagnosis and treatment goals Review all diagnostic reports and provide clinical direction to the study team Qualifications Requirements: 10 years' post training experience as a physician Currently licensed to practice medicine in the state of hire with no history of license suspension or debarment Current board certification in specialty area Advanced knowledge of treatment and drug interactions Ability to build rapport with patients and biopharmaceutical sponsors Strong attention to detail Strong leadership qualities Provide clinical oversight to study team Clinical research experience preferred Additional Information About M3USA M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. M3 reserves the right to change this job description to meet the business needs of the organization Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Other Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at M3 Wake Research by 2x Sign in to set job alerts for “Clinical Research Physician” roles. 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