Senior Medical Director, Neuroscience Clinical Development
About The Position
Oversees the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data that supports overall product scientific and business strategy. Manages clinical development programs in support of the Product Development Plan, applying medical and scientific principles and knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees education for investigators, study-site personnel, and AbbVie study staff. Has overall responsibility for clinical study oversight, study integrity, review and interpretation of accumulating safety and efficacy data, serious adverse event assessment and reporting for assigned protocols, and coordination with Clinical Operations on enrollment and key timelines. Provides scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee Medical Directors, Scientific Directors, and Clinical Scientists. Serves as in-house clinical expert for the molecule and disease area, coordinates relevant internal scientific and medical activities, and may contribute to business development and translational strategy. May serve on or chair an Integrated Evidence Strategy Team, developing a rigorous, cross-functionally aligned Clinical Development Plan that considers contingencies and alternatives. May supervise matrix team members and represent Clinical Research on an Asset Strategy Team. Builds clinical interfaces and seeks opinion-leader input, partnering with Medical Affairs, Commercial, and other functions as appropriate. Maintains therapeutic-area expertise, represents clinical development in regulatory discussions, and ensures compliance with regulatory requirements, Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Requirements
- M.D., D.O., or non-US equivalent M.D. degree with a relevant therapeutic specialty in an academic or hospital environment.
- At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to run a moderately complex clinical research program with minimal supervision.
- Ability to perform effectively and bring out the best in others on a cross-functional global team.
- Ability to interact internally and externally to support a global scientific and business strategy.
- Knowledge of clinical trial methodology and regulatory and compliance requirements governing clinical trials.
- Experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.
Nice To Haves
- Completion of a residency program is strongly preferred.
- Completion of a subspecialty fellowship is desirable.
- Experience with psychedelic drug development is highly preferred.
Responsibilities
- Manage the design and implementation of clinical development programs in support of the overall Product Development Plan.
- Oversee education of investigators, study-site personnel, and AbbVie study staff.
- Monitor clinical study integrity and review, interpret, and communicate accumulating safety and efficacy data.
- Coordinate with Clinical Operations on study enrollment and timelines for key deliverables.
- Assess and report serious adverse events for assigned protocols in accordance with corporate policy and regulations.
- Design, analyze, interpret, and report scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- Provide clinical expertise on the molecule and disease area and coordinate scientific and medical activities with internal stakeholders.
- Contribute to due diligence, business development, and translational strategies as needed.
- Participate in or chair an Integrated Evidence Strategy Team and develop a cross-functionally aligned Clinical Development Plan.
- When serving as IEST Chair, potentially supervise matrix team members and represent Clinical Research on an Asset Strategy Team.
- Solicit opinion-leader input and partner with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into development plans and protocols.
- Maintain therapeutic-area expertise through conferences, medical literature, and other training.
- Represent clinical development in key regulatory discussions and ensure understanding of applicable regulatory requirements.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
