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 product scientific and business strategy. Manages clinical development programs in support of the overall Product Development Plan, applying medical and scientific principles and knowledge of compliance, regulatory requirements, customers, markets, business operations, and emerging issues. Provides project-related education to investigators, study-site personnel, and AbbVie study staff. Oversees clinical studies, study integrity, accumulating safety and efficacy data, enrollment, and key deliverable timelines. Assesses and reports serious adverse events in accordance with corporate policy and regulations for assigned protocols. Leads the design, analysis, interpretation, and reporting of 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 working on the same or related programs. Provides internal clinical expertise on the molecule and disease, coordinates scientific and medical activities with stakeholders, and may contribute to due diligence, business development, and translational strategies. May serve on or chair an Integrated Evidence Strategy Team (IEST), developing a cross-functionally aligned Clinical Development Plan that considers contingencies and alternatives. An IEST Chair may supervise matrix team members and represent Clinical Research on an Asset Strategy Team. Serves as a clinical interface with opinion leaders and partners with Medical Affairs, Commercial, and other functions as appropriate and consistent with corporate policies. Maintains therapeutic-area expertise through conferences, medical literature, and training. Understands and complies with regulatory requirements for clinical studies and global drug development, represents the clinical function in key regulatory discussions, and ensures adherence to 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 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 in 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 Product Development Plan.
- Oversee education of investigators, study-site personnel, and AbbVie study staff.
- Oversee clinical studies and study integrity, and review, interpret, and communicate accumulating safety and efficacy data.
- Oversee study enrollment and timelines for key deliverables in partnership with Clinical Operations.
- 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.
- May oversee Medical Directors, Scientific Directors, and Clinical Scientists working on the same or related programs.
- Provide in-house clinical expertise for the molecule and disease and coordinate scientific and medical activities with internal stakeholders.
- May participate in due diligence or other business development activity and contribute to translational strategies with Discovery colleagues.
- May serve on or chair an Integrated Evidence Strategy Team and develop a rigorous, cross-functionally aligned Clinical Development Plan that considers contingencies and alternative approaches.
- As IEST Chair, may supervise matrix team members and represent Clinical Research on an Asset Strategy Team.
- Solicit opinion leader interactions and partner with Medical Affairs, Commercial, and other functions as appropriate.
- Maintain expertise through conferences, medical literature, and other training.
- Understand and comply with regulatory requirements for clinical studies and global drug development, and represent the clinical function in key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- 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
