Senior Vice President, Clinical Development Oncology
New
USFull-TimeVp
Salary300,000 - 450,000 USD per year
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Job Details
- Experience
- 10–15+ years
- Required Skills
- GCP
Requirements
- Medical Doctor (MD) required with extensive clinical development experience in oncology.
- 10–15+ years of experience in biotech or pharmaceutical clinical development, with deep expertise in oncology programs.
- Strong experience in late-stage clinical development and regulatory submissions, including NDA and/or BLA leadership.
- Demonstrated track record of leading interactions with global health authorities (FDA, EMA, MHRA) from a clinical development perspective.
- Experience in liver cancer indications (HCC and/or cholangiocarcinoma) strongly preferred.
- Deep understanding of GCP, ICH guidelines, FDA regulations, and global oncology trial design principles.
- Proven ability to interpret complex clinical datasets and translate them into actionable development and regulatory strategies.
- Experience working in startup or emerging biotech environments with a hands-on leadership approach.
- Strong leadership skills with experience building and guiding multidisciplinary clinical development teams.
- Exceptional communication, scientific rigor, and ability to represent clinical strategy in high-stakes internal and external settings.
Responsibilities
- Lead the overall clinical development strategy for oncology programs, with emphasis on liver cancers including cholangiocarcinoma and hepatocellular carcinoma, across all stages of development through registration.
- Design, oversee, and execute integrated clinical development plans, including Phase 1–3 trials and pivotal registrational studies.
- Provide senior leadership for clinical study design, protocol development, execution, and interpretation of clinical trial data.
- Ensure clinical data quality, robustness, and regulatory readiness to support NDA/BLA submissions and global approvals.
- Lead clinical development contributions to regulatory interactions, including FDA, EMA, MHRA meetings, scientific advice, and submission discussions.
- Drive preparation and review of key regulatory documentation, including clinical summaries, integrated analyses, safety narratives, and submission-critical materials.
- Respond to health authority inquiries and guide development of strategic responses during regulatory review cycles.
- Collaborate with Regulatory Affairs and cross-functional teams to ensure alignment between clinical strategy and regulatory expectations.
- Contribute to pipeline strategy, due diligence, and evaluation of internal and external oncology opportunities.
- Provide scientific and clinical leadership across study documents, including protocols, SAPs, CRFs, and clinical interpretation frameworks.
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