Senior Director Medical Affairs
For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.
Location: Open to considering candidates in San Diego, CA or Princeton, NJ
The Senior Medical Director will provide medical/scientific, strategic, and operational expertise into the planning and execution of medical affairs activities, with a key focus on Phase IV study planning and execution. This position reports into the SVP, Global Head of Medical Affairs.
- Plan and execute the Medical Affairs Phase IV study program to address data needs in specific indications related to Acadia’s products in collaboration with other functions, including regulatory, commercial, clinical development, and clinical operations
- Lead the development of presentations and updates to senior management on the phase 4 program
- Provide ongoing technical and medical expertise to execute on these strategies
- Partner with Clinical Operations in efficient execution of the phase IV study program, including oversight of CROs, compliance with company’s policies and procedures, and study budget management
- Provide medical expertise and editorial support in the data dissemination from clinical and non-interventional studies at conferences and in medical journals
- Provide support to the HEOR team for non-interventional studies
- Establish appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
- Plan and develop content for advisory board meetings with opinion leaders on data generation strategies
- Serve as Medical Affairs representative on cross-functional teams supporting phase 2/3 pipeline products
- The Senior Medical Director, Medical Affairs will have a M.D., D.O., or equivalent degree with a minimum 10 years of progressive experience in the biotech or pharmaceutical industry, including hands-on experience in the strategic management and execution of Phase IV clinical trials. Phase III will also be considered. Research experience in CNS preferred.
- Knowledge of scientific methods, research design and medical practices and procedures
- Excellent written and oral communication skills, including strong formal presentation skills
- Excellent planning and organization skills
- Strong interpersonal skills
- Ability to maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behavior, and professionalism
- Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants
- High proficiency in problem solving ability and strong scientific analytical skills
- Ability to travel (frequent travel may be required)
- Strong computer skills (Microsoft Office, etc.) and knowledge of database management (Veeva Vault, etc.)
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Determines methods and procedures on new assignments and may coordinate activities of other personnel.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity