Main Responsibilities
- Develop and execute an integrated US Medical Plan for Dermatology products, including MSL, medical education/communications/publications, health outcomes, safety, and clinical research (Phase IIIBβIV and IST).
- Manage annual budget; ensure on-time/on-budget delivery; communicate progress to internal stakeholders.
- Provide evidence/data to align medical strategy with clinical development and commercial objectives.
- Lead medical engagement planning; provide medical expertise to Clinical, Commercial, Market Access, and Regulatory partners.
- Oversee clinical study execution (GCP/ICH): protocols, CRFs, study/statistical plans, guidelines, reporting; review/approve IST concepts/protocols.
- Identify and oversee post-marketing trials/registries; ensure timely, fair public presentation of data.
- Partner on safety: adverse events, post-marketing safety data, and communication of safety signals/product alerts.
- Review/approve promotional and medical materials; review scientific/medical content across multiple functions; review applications and training materials for medical education.
- Maintain knowledge of relevant guidance/law; build relationships with Key Thought Leaders; lead advisory board discussions; provide disease state/product training.
Qualifications
- PhD, PharmD, PA, NP, or MD (relevant experience).
- 5+ years in Medical Affairs.
- Strong US medical strategy execution track record; Dermatology and/or Immunology experience strongly preferred.
- Experience in medical affairs launch and lifecycle management; clinical trial design/execution knowledge.
- Deep understanding of healthcare/regulatory/payer landscape, scientific/clinical judgment, leadership and cross-functional stakeholder management, strong communication and presentation skills.
Benefits (if part of job description)
- Health and wellbeing benefits; at least 14 weeksβ gender-neutral parental leave.