Job Description
The Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities, including HCP/provider interactions; generation of clinical/scientific data; educational initiatives; and safeguarding patient safety. Works closely with sales, marketing, and commercial teams to provide strategic medical input into brand strategies and to support medical affairs and market access.
Key Responsibilities:
- Initiate medical affairs activities (data generation/dissemination strategy; develop Global Medical Affairs strategy; deliver Medical Functional Plan/Brand Plan; ensure execution with Area/Affiliates).
- Design, analyze, interpret, and report scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions/responses.
- Oversee Medical Affairs-led clinical studies; ensure integrity; interpret/communicate accumulating safety and efficacy data; provide in-house clinical expertise.
- Contribute to clinical trial safety; resolve safety issues; safety monitoring; review and assess all AEβs and SAEβs.
- Serve as clinical interface; solicit expert input via leader interactions; support cross-functional Clinical Development Plans/protocols.
- Support scientifically accurate marketing materials, medical education, advisories, symposia; review/approve and communicate supported affiliate/area/global clinical research.
- Coordinate scientific/medical activities with internal stakeholders; interface for key regulatory discussions.
- Provide scientific/medical education; remain current via conferences/literature.
- Ensure budgets/timelines/compliance are factored into scientific programs.
- Understand and comply with regulatory requirements for clinical studies and global drug development.
Qualifications:
Experience Requirements
Scientific Director:
- PhD or PharmD (post-doctorate highly preferred); 10β15+ years in pharma; 7β10 years Medical Affairs with Global Medical Affairs experience highly preferred.
Senior Medical Director:
- M.D. (or equivalent D.O./non-US M.D.); academic/hospital specialty preferred; residency/fellowship preferred; 2+ years in clinical trials or medical affairs (5 years preferred).
Additional Qualifications:
- Therapeutic area expertise required; multiple myeloma expertise highly preferred.
- Clinical trial methodology, data analysis/interpretation, regulatory requirements; experience in protocol design and development strategy.
- Proven cross-functional global leadership; external/internal interaction skills.
- Excellent oral/written English communication.
Location/Schedule:
- Ideally Mettawa, IL or Florham Park, NJ; other U.S. sites may be considered; hybrid schedule 3 days/week onsite.