Senior Vice President, Clinical Development, Oncology

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Elevar Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2019

💰 $20M Venture Round - Elevar Therapeutics on 2018-07

Elevar Therapeutics is a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options.

📋 Description

• 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

• 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

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