Senior Vice President, Clinical Development, Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the comprehensive clinical development strategy for oncology programs, primarily targeting cholangiocarcinoma and hepatocellular carcinoma, from early development stages through late-stage and registration-enabling studies.

• Create and implement integrated clinical development plans that align with regulatory goals, which include the design, execution, and analysis/interpretation of study protocols in collaboration with other relevant functional leaders.

• Manage study design, protocol formulation, and execution for Phase 1-3 clinical trials, including pivotal registrational cancer studies.

• Offer expert oversight for clinical data analysis and interpretation, ensuring that data is robust, clinically relevant, and suitable for regulatory decision-making.

• Contribute to the pipeline strategy and due diligence for new internal and external oncology opportunities by providing senior clinical and regulatory development insights.

• Act as the clinical development lead for global regulatory engagements, collaborating closely with Regulatory Affairs to define strategic direction and messaging.

• Lead and actively engage in discussions with regulatory agencies (e.g., FDA, EMA, MHRA), including scientific advice, End-of-Phase meetings, pre-NDA/BLA submissions, and other ad hoc regulatory interactions from a clinical development viewpoint.

• Provide senior clinical oversight and guidance during the review of NDA and/or BLA clinical components, including clinical summaries, integrated analyses, and necessary study documentation.

• Guide the clinical development input for responses to health authority inquiries, encompassing written replies to information requests, major review questions, and post-submission clarifications.

• Ensure that clinical strategy, trial design, and data presentation align with evolving regulatory guidance and agency feedback throughout the product lifecycle.

• Maintain the quality, consistency, and regulatory readiness of all clinical documentation, including Investigators’ Brochures, protocols, Clinical Study Reports (CSRs), safety narratives, and critical submission documents.

• Provide senior scientific and clinical insights into study-related documentation, including Informed Consent Forms (ICFs), Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), clinical pharmacology analysis plans, and data interpretation narratives.

⛳️ Requirements

• MD degree required, with significant relevant clinical development experience.

• 10-15+ years of clinical development experience in the biotech or pharmaceutical industry, with a strong emphasis on oncology.

• Direct experience in liver cancers (HCC, cholangiocarcinoma) is highly preferred.

• Experience in a start-up or emerging biotech environment is preferred.

• Proven expertise in late-stage development and regulatory submission support, including clinical leadership for NDA and/or BLA filings and responses to health authority feedback.

• Demonstrated ability to lead regulatory interactions from a clinical development perspective and to convert agency feedback into actionable development plans.

• In-depth understanding of GCP, ICH, FDA, and global regulatory requirements, oncology trial design, and the interpretation of complex clinical datasets.

• Experience successfully operating in a start-up or emerging biotech environment is strongly preferred.

• Strong history of building and leading multidisciplinary clinical teams and influencing across functions.

• Commitment to ethics, patient safety, and scientific rigor, with the capability to credibly represent the company in both internal and external contexts.

• Ability to prioritize tasks effectively and operate in a fast-paced, remote, and rapidly changing environment with a proactive, “get-it-done” attitude.

• Capability to embody Elevar’s core values by holding ourselves and each other accountable for our work, collaborating effectively while working remotely, fostering innovation in work and thought, and remaining grounded in compassion with a commitment to prioritizing patients.

🏝️ Benefits

• Medical

• Dental

• Vision

• Time off

• Retirement plan

• Additional voluntary benefits