Sr./Executive Medical Director
Position Overview:
As the clinical lead, you will play a critical role in the design, implementation, and scientific oversight of clinical development programs in I&I. The role combines scientific leadership with hands-on study execution within a small, agile development team with high visibility, requiring initiative, ownership, and effective communication. This position is primarily remote with periodic travel. West Coast location is preferred. This position reports to the CSO.
Key Responsibilities:
- Clinical Development: Design and implementation of clinical study protocols, particularly early-phase, proof-of-concept studies. Coordinate development of protocol and study design documents with input from cross-functional stakeholders. Assess study elements through literature review and scientific evaluation, including endpoints, eligibility criteria, dosing strategy, statistical considerations, and other protocol components for team discussion.
- Data Review: Perform ongoing review and interpretation of clinical safety and efficacy data, including direct evaluation of subject-level data in EDC and clinical data review systems. Identify emerging signals and translate findings into study recommendations and program insights.
- Implementation: Study implementation with clinical operations and CRO partners. Provide scientific input for site questions, CRO inquiries, IRB/EC communications, and regulatory requests. Remain engaged in study details to resolve issues and maintain study progress.
- Collaboration: Work with internal and external stakeholders including clinical operations, biometrics, regulatory, pharmacovigilance, and translational teams to align study design, data review, and operational execution and facilitate cross-functional coordination for study progress.
- External Interactions: Engage investigators and key opinion leaders as needed for study design and study conduct. Contribute to preparation and review of protocols, investigator brochures, clinical study reports, regulatory submissions, and scientific presentations or publications as appropriate.
Experience and Required Skills:
- Advanced degree in medicine, life sciences, or related discipline (e.g., MD) required.
- Minimum 5 years clinical development or clinical science experience in the pharmaceutical or biotechnology industry, with demonstrated experience contributing to clinical study design and protocol development, plus clinical data review and interpretation.
- Experience in early clinical development (Phase 1-2) preferred.
- Therapeutic experience in Immunology & Inflammation (dermatology, respiratory, rheumatology, or inflammatory bowel disease) desirable.
- Ability to lead or contribute to clinical trial design and perform review and interpretation of clinical data. Familiarity with clinical data review systems (e.g., EDC).
- Ability to influence cross-functional teams through clear communication, scientific credibility, and emotional intelligence.
- Combination of detail-oriented execution and strategic thinking. Comfortable operating with autonomy in a fast-moving development environment.
- Ability to work flexible hours supporting global collaborations.
- Approximately 10-25% travel, including investigator meetings, site visits, and scientific conferences.
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