Senior Vice President, Clinical Development Oncology

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Vice President, Clinical Development Oncology based in the United States.

This executive leadership role is responsible for shaping and driving the full clinical development strategy for a high-impact oncology pipeline, with a strong emphasis on late-stage execution and regulatory success. The position plays a critical role in advancing programs from early clinical phases through pivotal trials and submission readiness, ensuring scientific rigor and regulatory alignment at every stage. It involves direct engagement with global health authorities and oversight of NDA/BLA-enabling activities, making it central to the success of the organization’s therapeutic development strategy. Operating in a fast-paced biotech environment, this leader must balance strategic vision with hands-on execution, guiding complex clinical and regulatory decisions. The role also requires close collaboration across clinical, regulatory, and scientific functions to ensure data integrity, trial excellence, and submission readiness. This is a highly visible position with direct impact on oncology drug development and patient outcomes.

• 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.

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.

Benefits:

• Competitive annual base salary ranging from $300,000 to $450,000
• Comprehensive medical, dental, and vision insurance coverage
• Retirement plan with employer-supported benefits
• Paid time off and flexible remote work arrangements
• Voluntary benefits and additional employee support programs
• Opportunity to lead high-impact oncology programs with direct regulatory and clinical influence
• Strong focus on scientific excellence, patient impact, and innovation-driven culture
• Work within a fast-growing biotech environment with significant leadership visibility