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Lead Oncology Clinical Development
2 months ago
Bicycle Therapeutics is seeking a highly motivated physician leader with extensive oncology drug development experience to serve as Vice President, Clinical Development. This leadership role will be based in either Cambridge, UK or Cambridge, MA and will contribute significantly to the growth of our clinical development organization within the exciting field of oncology.
Reporting directly to the Chief Development Officer, you will play a pivotal role in shaping the clinical development strategy for our portfolio of novel Bicycle (bicyclic peptide) therapeutics. These innovative molecules are designed using our proprietary platform and hold immense potential in the fight against cancer.
This strategic position demands both high-level leadership and hands-on program management. You will be responsible for overseeing study conduct, program activities, and clinical development plans across the entire portfolio. Your expertise will guide the advancement of these groundbreaking molecules from IND to POC to NDA submissions, ensuring rigorous scientific standards throughout the process.
Key Responsibilities:
- Provide scientific, clinical, and product development leadership for all development programs within the Bicycle portfolio.
- Lead a cross-functional, matrix team of physicians, clinical scientists, and other development professionals.
- Contribute specialized therapeutic area expertise to enhance innovation and efficiency in clinical trial design and execution.
- Develop and refine comprehensive clinical development plans for Bicycle's portfolio, encompassing all stages from IND to NDA submission.
- Play a crucial role in IND, NDA, and PMA submissions by overseeing medical documentation and actively participating in meetings with regulatory agencies.
- Serve as the clinical lead for early-stage development studies, including study design, protocol writing, regulatory document preparation, CRO interactions, study startup, investigator engagement, data monitoring, health authority communications, analyses, and study reporting.
- Establish and cultivate strong relationships with investigators and thought leaders in close collaboration with the Medical Affairs function.
- Contribute to scientific advisory boards, conference activities, external collaborations, and partnerships.
- Provide medical, disease-specific, and development perspectives to specific research programs or broader research initiatives.
Qualifications:
- Medical Doctor (MD/MBBS/DO) degree.
- Ideally a medical oncologist, or possess a deep understanding of oncology, including companion diagnostics, precision oncology drug development paradigms, clinical pharmacology, and technical, business, and regulatory approaches.
- Exceptional interpersonal and communication skills, both written and oral, with the ability to convey complex information clearly and concisely.
- Strong leadership abilities and a collaborative approach to working within diverse teams.
