Sr Medical Director/Executive Medical Director - Neuroscience Clinical Development - Toxins
About The Position
Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting the overall product scientific and business strategy. The role focuses on neuroscience clinical development involving toxins. The position owns or oversees the design and implementation of clinical development programs, clinical study teams, study integrity, and the review and communication of safety and efficacy data. It is responsible for scientific content in core clinical and regulatory documents, may oversee other medical or scientific staff, and may chair Clinical Strategy Teams. The role serves as an in-house clinical expert, works with internal and external stakeholders, supports regulatory discussions, and ensures that research complies with Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality requirements.
Requirements
- M.D., D.O., or non-US equivalent medical degree with relevant therapeutic specialty experience in an academic or hospital environment.
- At least 5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to independently run a complex clinical research program.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team, including leading through influence.
- Ability to interact internally and externally to support a global scientific and business strategy.
- Extensive 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.
- Ability to exercise judgment, address complex problems, and create solutions for one or more projects.
Nice To Haves
- Completion of a residency program is strongly preferred.
- Completion of a subspecialty fellowship is desirable.
- Seven years of clinical trial experience is preferred.
Responsibilities
- Lead the design and implementation of multiple clinical development programs, or one large and complex program, in support of the overall product development plan.
- Oversee project-related education for investigators, study site personnel, and AbbVie study staff.
- Lead clinical study teams, monitor study integrity, and review, interpret, and communicate accumulating safety and efficacy data.
- Work with Clinical Operations to help ensure agreed-upon study enrollment and timelines for key deliverables.
- Assess and report serious adverse events in accordance with corporate policy and regulations for assigned protocols.
- Own the design, analysis, interpretation, and reporting of scientific content in protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- May oversee Medical and/or Scientific Directors and Clinical Scientists working on related programs.
- May serve on or chair Clinical Strategy Teams and develop cross-functionally aligned Clinical Development Plans, including contingencies and alternative approaches.
- When serving as Clinical Strategy Team Chair, may supervise matrix team members and represent Clinical Research on Asset Development Teams and their Leadership Boards.
- Serve as an in-house clinical expert for molecules and diseases in the therapeutic area, coordinating scientific and medical activities with internal stakeholders.
- May contribute clinical development expertise to due diligence and other business development activities.
- Partner with Discovery colleagues, as needed, on translational strategy design and implementation.
- Lead clinical activities and opinion-leader interactions related to the disease area, partnering with Medical Affairs, Commercial, and other functions as appropriate.
- Maintain therapeutic-area expertise through conferences, medical literature, and training; may represent AbbVie at external meetings.
- Understand and comply with regulatory requirements for clinical studies and global drug development, and serve as a clinical representative 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 time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
