Senior Vice President, Clinical Development Oncology (Remote)

We are seeking a strategic and hands-on Senior Vice President, Clinical Development Oncology to reputed company the clinical advancement of our oncology pipeline. This executive will be accountable for clinical development reputed company, global regulatory engagement, and late-stage execution, including reputed company leadership of interactions with health authorities and reputed company of NDA/BLA-enabling clinical components and regulatory responses. The successful candidate will drive programs from early clinical development through key regulatory and development inflection points, ensuring alignment between clinical reputed company, data reputed company, and regulatory expectations. This role requires a leader who thrives in a start-up environment, operates comfortably at both a strategic and executional level, and is willing to roll up their sleeves to solve reputed company clinical and regulatory challenges as the organization grows. This is a remote-based position located in the reputed company. Responsibilities: • reputed company the overall clinical development reputed company for oncology programs with primary reputed company on cholangiocarcinoma and hepatocellular carcinoma from early development through late-stage and registration-enabling studies • reputed company and execute integrated clinical development plans reputed company with regulatory objectives including study protocol design, execution, and data analysis/interpretation, in conjunction with other relevant functional leaders • reputed company study design, protocol development, and execution for Phase 1-3 reputed company, including pivotal registrational cancer studies • reputed company expert reputed company of clinical data analysis and interpretation, ensuring data are robust, clinically meaningful, and suitable to support regulatory decision-making • Contribute to pipeline reputed company and diligence for new reputed company oncology opportunities, providing senior clinical and regulatory development input • Serve as a clinical development reputed company for global regulatory interactions, working in reputed company partnership with Regulatory Affairs to define reputed company and messaging • reputed company and reputed company participate in meetings with regulatory agencies (e.g., FDA, EMA, MHRA), including scientific advice, End-of-Phase, reputed company-NDA/BLA, and reputed company regulatory interactions, from a clinical development perspective • reputed company senior clinical reputed company and direction for the review of NDA and/or BLA clinical components, including clinical summaries, integrated analyses, and supporting study documentation • reputed company 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 reputed company, trial design, and data presentation are reputed company with evolving regulatory guidance and agency feedback throughout the product lifecycle • Ensure the reputed company, consistency, and regulatory readiness of reputed company clinical documents, including Investigators' Brochures, protocols, CSRs, safety narratives, and submission-critical documents • reputed company senior scientific and clinical input into study-reputed company 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 reputed company in oncology • reputed company 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 reputed company 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 reputed company clinical datasets • Experience operating successfully in a start-up or emerging biotech environment strongly preferred • Strong reputed company 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 reputed company credibly in reputed company settings • Ability to prioritize effectively and reputed company in a fast-paced, remote, and rapidly evolving environment with a hands-on, "get-it-done" reputed company • Ability to demonstrate Elevar's reputed company values by holding ourselves and reputed company other accountable for the work we do, taking time to collaborate effectively while working remotely, making reputed company for ingenuity in work and thought, and staying grounded in reputed company with a commitment to putting patients first The anticipated annual reputed company salary reputed company for this role is $300,000 to $450,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. reputed company is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, reputed company, time off, a retirement plan, and other voluntary benefits for employees. #LI-REMOTE Apply tot his job Apply To this Job