VP, Hematology, Clinical Development
3 weeks ago
A clinical-stage biopharmaceutical company based in Boston, MA has an exciting pipeline in genetically defined rare diseases in areas of high unmet medical need. They are seeking a VP, Hematology, Clinical Development to take their lead asset in sickle cell forward and to further develop a range of early phase non-malignant hematology assets.
In this role, you will lead the clinical design and conduct for assigned studies or programs, direct KOL engagement and be the medical lead on multi-disciplinary clinical teams.
Responsibilities
- Lead and oversee early and late-stage clinical development plans, including design, author, and execute clinical trials for clinical programs across development phases to ensure execution of high-quality clinical trials that meet key milestones, maintain timelines, and stay within budget.
- Provide clinical leadership to support development and advancement of preclinical assets.
- Provide clinical leadership in preparation of clinical protocols, regulatory documents, and regulatory agency interactions, including an active presence in internal governance and review committees.
- Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data, safety and efficacy trials.
- Establish strong external networks of thought leaders in collaboration with members in clinical, medical affairs and R&D, to support clinical development strategies and help optimize program plans and protocols.
Qualifications
- M.D. 10+ years of pharmaceutical/biotech-industry clinical development experience.
- Therapeutic expertise in non-malignant hematology a must.
- Prior experience with clinical protocol development and study conduct in biotech or pharmaceutical companies
You will be joining a well resourced and financed biotech and will lead a motivated and focused team. The company is looking for someone to work on a hybrid basis in the Boston area but will offer flexibility.
For more information on the company and their excellent compensation and stock scheme please CLICK APPLY and forward your resume.
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