Senior Vice President, Clinical Development
Skills
- Senior leadership in clinical development and program management
- Clinical trial design and conduct across early to late‑stage studies
- Clinical protocol and regulatory document writing
- Medical monitoring and safety oversight
- Experience collaborating with pharmacovigilance, biostatistics, and clinical operations
- Strong knowledge of FDA, EMA, ICH, and GCP guidelines
- Exceptional written and verbal communication skills
- Ability to present clinical data to diverse audiences and external stakeholders
- Experience working with CROs, KOLs, and trial investigators
- Willingness to travel domestically and internationally (~20-30%)
Responsibilities
- Provide clinical scientific leadership for the clinical development organization and cross‑functional workstreams.
- Lead design and writing of clinical protocols and associated study documents.
- Provide medical safety oversight and collaborate with pharmacovigilance on safety analyses and presentation to safety boards.
- Draft and contribute to regulatory documents (IND, NDA, BLA, Investigator Brochures, CSRs, DSURs) and responses.
- Serve as sponsor medical monitor and primary medical representative for clinical studies.
- Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, and external CROs to ensure conduct and timelines.
- Prepare and present clinical data for advisory boards, regulatory meetings, investigators, and scientific conferences.
- Support publications and manuscript development related to clinical trial data.
- Ensure compliance with ICH, GCP, SOPs and lead preparation for audits and regulatory inspections.
Education
- MD, DO, or non‑US equivalent medical degree
- Postgraduate clinical training (residency) preferred
Benefits
- Equity/stock compensation opportunities
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Unlimited paid time off and parental leave
- Remote work and flexible environment
- Professional development and conference support
- Competitive total compensation package including bonuses
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Scientific Systems Company Inc. is seeking a Senior Research Engineer II to develop and test advanced guidance, navigation, and control and autonomy solutions for aerial and space vehicles, including simulation and hardware-in-the-loop integration.
Lead the technical development and commercialization of vertical GaN power devices as a senior device authority, driving device architecture, modeling, process integration, and reliability at a fast-moving startup.
The University of Stuttgart is going to increase its international presence and concentrate on themes that are of central importance to the future. Behind this lies the vision of undertaking research on the whole life-cycle of a product. This begi...
1 jobs
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
Proudly made in NYC.
