Elevar Therapeutics, Inc - Senior Vice President, Clinical Development Oncology (Remote)

We are seeking a strategic and hands-on Senior Vice President, Clinical Development Oncology to lead the clinical advancement of our oncology pipeline. This individual will be responsible for shaping and executing clinical development strategies, leading regulatory interactions, and driving programs from early development through key inflection points.

This role requires a leader who thrives in a startup environment - someone who can operate at both a strategic and executional level, proactively solve problems, and help build the clinical function as the company grows. This is a remote-based position located in the United States.

Responsibilities:

• Lead the overall clinical development strategy for programs in cholangiocarcinoma and hepatocellular carcinoma
• Develop strategic clinical development plans and oversee protocol design, execution, and data analysis/interpretation, in conjunction with other relevant functional leaders
• Manage, build, and lead a clinical team (including SMEs in such areas as clinical operations, clinical pharmacology, nonclinical, and biostatistics) to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH guidelines, and other global regulatory requirements
• Interface with global regulatory authorities, as appropriate, in support of the clinical development objectives; supports the completion and approval of study-related documents (e.g., study reports) for regulatory authorities and ethics committees
• Lead efforts to build relationships and communicate with key investigators and to identify trial sites to ensure successful execution of clinical studies in compliance with global regulatory requirements
• Direct study design, protocol development, and execution of clinical research for Phase 1 to 3 studies including pivotal cancer studies
• Contribute to the overall clinical strategy of the ongoing clinical development programs and product pipeline as well as giving in-depth clinical development advice on potential new projects (internal and external)
• Generate/review clinical components of key documents in support of regulatory submissions, including clinical section of IND’s and NDA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
• Ensure quality of all clinical documents (e.g., Investigators’ Brochure, protocols, study reports, clinical components of regulatory submissions, safety-related documents)
• Provide scientific clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
• Analyze and interpret data expertly, and clearly communicate results both internally and externally
• Act as primary Medical Monitor, monitoring the safety of enrolled subjects on assigned trials

• MD strongly preferred