
Elevar Therapeutics
Remote Jobs
Elevating Outcomes, Evolving Therapeutic Potential, Engaging with Purpose
2 Jobs
Senior Vice President, Clinical Development, Oncology
Elevar TherapeuticsElevating Outcomes, Evolving Therapeutic Potential, Engaging with Purpose
• 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
Executive Director, Market Access
Elevar TherapeuticsElevating Outcomes, Evolving Therapeutic Potential, Engaging with Purpose
• Manage Accounts from Pre-Commercial through launch of Rivoceranib-Camrelizumab and Lirafugratinib • Obtain coverage across assigned accounts • Work closely with Trade/Patient Services, Payer Marketing, and Medical Affairs • Collaborate on workstreams and go to market plans • Be the main point of contact for internal and external stakeholders • Work closely with Access Marketing/Pricing/HEOR to develop and assess contractual proposals