The Senior Medical Director/Scientific Director, Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities for AbbVieβs Rheumatology SpA Therapeutic Area.
Responsibilities:
- Engage with health-care professionals and providers; generate clinical and scientific data to enhance therapeutic benefit and value.
- Lead medical affairs activities, generation and dissemination of data supporting overall scientific strategy.
- 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 study integrity; interpret and communicate accumulating safety and efficacy data; oversee enrollment and key deliverable timelines.
- Provide in-house clinical expertise for the molecule and disease; coordinate scientific activities with internal stakeholders; may participate in due diligence/business development and translational strategy work.
- Serve as clinical interface; solicit opinion and incorporate cross-functional perspectives into Clinical Development Plans and protocols.
- Assist development/review of scientifically accurate marketing materials, medical education, advisories, and symposia; support affiliate/area/global medical affairs sponsored/supported clinical research.
- Coordinate scientific/medical activities with stakeholders; serve as scientific team interface for key regulatory discussions.
- Provide scientific/medical education; act as a therapeutic area resource.
- Ensure budgets, timelines, and compliance requirements are factored into scientific activities.
Qualifications:
- PhD or PharmD (additional post-do doctorate experience highly preferred).
- 7-10 years in Medical Affairs; Global Medical Affairs experience highly preferred.
- Typically 10-15 years in pharma or equivalent; strong therapeutic area knowledge required.
- Minimum 4 years clinical trials direct management experience (4+ years preferred).
- Knowledge of clinical trial methodology, data analysis/interpretation, and regulatory requirements; protocol design/development strategy experience.
- Ability to run clinical studies independently with little supervision.
- Proven cross-functional global leadership; excellent oral and written English communication.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.
Location/Work schedule: Mettawa, IL (or other locations); hybrid 3x/week onsite.