Scientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs)

The Scientific Director / Senior Medical Director provides specialist medical and scientific input into core medical affairs activities including healthcare professional/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 with sales, marketing, and commercial teams to provide strategic medical input into brand strategies and to support medical affairs and marketing activities (promotional material generation and product launches) and market access.

Position is ideally based in Mettawa, IL or Florham Park, NJ (other U.S. sites may be considered) with a hybrid schedule of 3 days/week onsite.

Key Responsibilities:
- Initiate medical affairs activities (data generation/dissemination strategy; develop Global Medical Affairs strategy; deliver Medical Functional Plan and Brand Plan; ensure execution with Area and Affiliates).
- Design/analyze/interpret/report scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions.
- Oversight of Medical Affairs-led clinical studies; monitor study integrity and review/interpret/communicate accumulating safety and efficacy data; provide in-house clinical expertise and coordinate scientific activities.
- Participate in clinical trial safety (M.D.s); resolve safety issues, safety monitoring, and regulatory scientific reports; review AE/SAEs.
- Serve as clinical interface and solicit input; incorporate cross-functional perspectives into Clinical Development Plans/protocols.
- Support scientific/accurate marketing materials, medical education programs, advisories, symposia; review/develop/approve/execute/communicate sponsored or supported clinical research activities.
- Coordinate medical/scientific activities with internal stakeholders; serve as scientific team interface for key regulatory discussions.
- Provide scientific/medical education; keep abreast of literature/conferences and act as therapeutic area resource.
- Ensure budgets, timelines, and compliance requirements are factored into scientific activities.
- Understand and comply with regulatory requirements for clinical studies and global drug development.

Qualifications:
Scientific Director
- PhD or PharmD; additional post-doctorate highly preferred.
- Typically 10–15 years in pharmaceutical industry/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-US M.D.); relevant specialty in academic/hospital environment preferred; residency/fellowship preferred.
- Minimum 2 years clinical trial or medical affairs experience (industry/academia); 5 years preferred.

Required/Preferred Skills:
- Direct therapeutic area expertise in multiple myeloma highly preferred; substantial understanding of therapeutic area required.
- Clinical trial methodology, data analysis/interpretation, regulatory requirements, and experience in development strategy/protocol design.
- Proven cross-functional global leadership.
- Ability to interact externally/internally to support global business strategy.
- Excellent oral and written English communication.

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for short-term incentive programs.

Application instructions:
- Not provided in the job description text.