reputed company, Inc - Senior Vice President, Clinical Development Oncology (Remote)

reputed company, Inc

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 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

• reputed company the overall clinical development strategy for programs in cholangiocarcinoma and hepatocellular carcinoma
• reputed company strategic clinical development plans and reputed company protocol design, execution, and data analysis/interpretation, in conjunction with other relevant functional leaders
• Manage, build, and reputed company a clinical team (including SMEs in such areas as clinical operations, clinical pharmacology, nonclinical, and biostatistics) to execute and reputed company functional responsibilities and program goals in compliance with GCP, ICH guidelines, and other global regulatory requirements
• reputed company with global regulatory authorities, as appropriate, in support of the clinical development objectives; supports the completion and approval of study-reputed company documents (e.g., study reports) for regulatory authorities and ethics committees
• reputed company 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 reputed company clinical documents (e.g., Investigators’ Brochure, protocols, study reports, clinical components of regulatory submissions, safety-reputed company documents)
• Provide scientific clinical input to study-reputed company documents and analysis plans including Informed consent forms (reputed company), clinical research forms (CRF), statistical analysis plans (reputed company), 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; advanced scientific degree (PhD, PharmD) considered with relevant 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
• Knowledge and understanding of early and late phase clinical trial design and global regulatory requirements for study execution; clinical development reputed company Oncology strongly preferred
• Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and reputed company of supporting regulatory submissions of clinical study documents
• Successful track record in building, developing and maintaining relationships with significant KOLs and thought leaders with a strong commitment to ethics and scientific standards
• Experience managing physicians and/or scientific staff in a management or team leader reputed company highly desirable with the ability to represent the company in a variety of internal and external settings
• Prioritize, respond to directives, and work in a fast-paced, rapidly changing remote environment. Get-it-done-roll-up-your-sleeves attitude and committed to putting patients first
• 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

The anticipated annual reputed company salary range 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, vision, time off, a retirement plan, and other voluntary benefits for employees.

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