Senior Vice President, Clinical Development, Oncology

Elevar Therapeutics

Senior Vice President, Clinical Development Oncology leading clinical advancement for oncology pipeline. Accountable for clinical strategy and regulatory engagement with a hands-on approach.

Posted 6/24/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $300,000 - $450,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the overall clinical development strategy for oncology programs with primary focus on cholangiocarcinoma and hepatocellular carcinoma from early development through late-stage and registration-enabling studies
Develop and execute integrated clinical development plans aligned with regulatory objectives including study protocol design, execution, and data analysis/interpretation, in conjunction with other relevant functional leaders
Direct study design, protocol development, and execution for Phase 1-3 clinical trials, including pivotal registrational cancer studies
Provide expert oversight of clinical data analysis and interpretation, ensuring data are robust, clinically meaningful, and suitable to support regulatory decision-making
Contribute to pipeline strategy and diligence for new internal and external oncology opportunities, providing senior clinical and regulatory development input
Serve as a clinical development lead for global regulatory interactions, working in close partnership with Regulatory Affairs to define strategy and messaging
Lead and actively participate in meetings with regulatory agencies (e.g., FDA, EMA, MHRA), including scientific advice, End-of-Phase, pre-NDA/BLA, and ad hoc regulatory interactions, from a clinical development perspective
Provide senior clinical oversight and direction for the review of NDA and/or BLA clinical components, including clinical summaries, integrated analyses, and supporting study documentation
Lead the clinical development contribution to responses to health authority questions, including written responses to information requests, major review questions, and post-submission clarifications
Ensure that clinical strategy, trial design, and data presentation are aligned with evolving regulatory guidance and agency feedback throughout the product lifecycle
Ensure the quality, consistency, and regulatory readiness of all clinical documents, including Investigators’ Brochures, protocols, CSRs, safety narratives, and submission-critical documents
Provide senior scientific and clinical input into study-related documentation, including ICFs, CRFs, SAPs, clinical pharmacology analysis plans, and data interpretation narratives

Requirements

What you’ll need

MD strongly preferred; advanced scientific degree (PhD, PharmD) considered with substantial relevant clinical development experience
10-15+ years of clinical development experience in biotech or pharmaceutical industry, with a strong focus in oncology
Direct experience in liver cancers (HCC, cholangiocarcinoma) strongly preferred
Experience in start-up or emerging biotech setting preferred
Demonstrated experience in late-stage development and regulatory submission support, including clinical leadership for NDA and/or BLA filings and responses to health authority feedback
Proven ability to lead regulatory interactions from a clinical development perspective and translate agency feedback into actionable development plans
Deep understanding of GCP, ICH, FDA, and global regulatory requirements, oncology trial design, and interpretation of complex clinical datasets
Experience operating successfully in a start-up or emerging biotech environment strongly preferred
Strong track record of building and leading multidisciplinary clinical teams and influencing cross-functionally
Demonstrated commitment to ethics, patient safety, and scientific rigor, with ability to represent the company credibly in internal and external settings
Ability to prioritize effectively and perform in a fast-paced, remote, and rapidly evolving environment with a hands-on, “get-it-done” mindset
Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion with a commitment to putting patients first.

Benefits

Comp & perks

competitive wages
medical
dental
vision
time off
a retirement plan
other voluntary benefits for employees

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical development strategystudy protocol designdata analysisPhase 1-3 clinical trialsNDABLAclinical data interpretationregulatory submission supportoncology trial designGCP

Soft Skills

leadershipcommunicationcollaborationprioritizationinfluenceethicspatient safetyscientific rigoradaptabilityaccountability

Certifications

MDPhDPharmD