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 and scientific data; educational initiatives (medical education, scientific communications, value proposition); and 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 materials and product launches) and market access.
Key Responsibilities:
- Initiate medical affairs activities: data generation and dissemination strategy; develop Global Medical Affairs strategy; deliver Medical Functional Plan and Brand Plan; ensure execution with Area and 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; monitor integrity; interpret and communicate accumulating safety/efficacy data; provide in-house clinical expertise and coordinate scientific activities with stakeholders.
- (M.D.s) Participate in clinical trial safety design/execution; provide scientific accountability for safety issues, safety monitoring, and regulatory-scientific reports; review AE/SAE.
- Act as clinical interface; solicit and incorporate cross-functional perspectives into Clinical Development Plans/protocols.
- Assist in development and scientific review/approval of marketing materials, medical education, advisories, symposia; support affiliate/area/global medical affairs-sponsored clinical research activities.
- Coordinate scientific/medical activities with internal stakeholders; serve as scientific interface for key regulatory discussions.
- Provide scientific/medical education; stay current with professional literature/conferences as therapeutic area resource.
- Ensure budgets, timelines, and compliance requirements are factored into scientific programs.
- Understand and comply with regulatory requirements for clinical studies and global drug development.
Work Location/Schedule:
- Ideally Mettawa, IL or Florham Park, NJ; other U.S. sites may be considered. Hybrid: 3 days/week onsite.
Qualifications
Experience Requirements
Scientific Director:
- PhD or PharmD (post-doctorate highly preferred)
- Typically 10β15 years in pharmaceutical industry/related
- 7β10 years in Medical Affairs with Global Medical Affairs experience highly preferred
Senior Medical Director:
- M.D. (or D.O. or non-US equivalent); relevant therapeutic specialty preferred; residency/fellowship preferred
- Minimum 2 years clinical trial or medical affairs experience (5 years preferred)
Required/Preferred Skills:
- Substantial therapeutic area understanding; direct multiple myeloma expertise highly preferred
- Clinical trial methodology, data analysis/interpretation, regulatory requirements; experience designing protocols and development strategy
- Proven cross-functional global leadership
- Ability to interact externally/internally to support global business strategy
- Excellent oral and written English communication