The Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities, including:
- Healthcare professional/provider interactions
- Generation of clinical and scientific data to enhance therapeutic benefit and value
- Educational initiatives (medical education, scientific communications, value proposition)
- Safeguarding patient safety (risk minimization and safety surveillance)
Works closely with sales, marketing, and commercial teams to provide strategic medical input into brand/product strategies and to support medical affairs/marketing activities (promotional material generation and product launches) and market access.
Location: Ideally based in Mettawa, IL or Florham Park, NJ (other U.S. sites may be considered). Hybrid schedule: 3 days/week onsite.
Key Responsibilities:
- Initiates medical affairs activities, including data generation/dissemination strategy; develops Global Medical Affairs strategy; delivers the Medical Functional Plan and Brand Plan; supports Area and Affiliates to execute strategy.
- Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions/responses.
- Oversees Medical Affairs-led clinical studies; ensures study integrity; interprets and communicates accumulating safety/efficacy data; provides in-house clinical expertise for the molecule and disease; coordinates scientific activities with internal stakeholders.
- Participates in design/execution of clinical trial safety (M.D.); accountable for resolution of safety issues, safety monitoring, and scientific reports to regulatory authorities; reviews and assesses all AE/SAE.
- Acts as clinical interface; solicits input via leader interactions; partners cross-functionally (Medical Affairs, Commercial, etc.) to incorporate perspectives into Clinical Development Plans and protocols.
- Helps develop scientifically accurate marketing materials, medical education programs, advisories, and symposia; supports affiliate/area/global medical affairs-sponsored clinical research activities.
- Coordinates scientific/medical activities with internal stakeholders (commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc.); serves as scientific interface for key regulatory discussions.
- Provides scientific/medical education to investigators, clinical monitors, and Global Project Teams; stays current through conferences and medical literature as a therapeutic area resource.
- Ensures budgets, timelines, and compliance requirements are factored into scientific programs.
- Understands and complies with regulatory requirements for clinical studies and global drug development.
Qualifications
Experience Requirements:
Scientific Director
- PhD or PharmD (advanced degree); additional post-doctorate experience highly preferred.
- Typically 10–15 years in the pharmaceutical industry or related.
- 7–10 years in Medical Affairs with Global Medical Affairs experience highly preferred.
Senior Medical Director
- M.D. or equivalent (D.O. or non-U.S. M.D. equivalent); relevant therapeutic specialty in an academic/hospital environment preferred; residency and/or fellowship preferred.
- Minimum 2 years of clinical trial or medical affairs experience in pharma/academia or equivalent (5 years preferred).
Required/Preferred Skills:
- Substantial understanding of the relevant therapeutic area; direct subject matter expertise in multiple myeloma highly preferred.
- Knowledge of clinical trial methodology; data analysis and interpretation; regulatory requirements for clinical trials; experience with development strategy and protocol design.
- Proven leadership in cross-functional global teams.
- Ability to interact internally/externally to support global business strategy.
- Excellent oral and written English communication skills.