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VP Pharmaceutical Development Lead
2 months ago
Rx Group is seeking a highly skilled and experienced VP Pharmaceutical Development to join their team in Cambridge, Massachusetts. This is a pivotal role in a clinical-stage company, offering the unique opportunity to directly contribute to the success of programs, hire a team, and influence the culture of the department.
Key Responsibilities:- Provide strategic, operational, and research leadership to drive the end-to-end process and product development of the pipeline, utilizing internal and external teams, from pre-clinical stages to commercialization.
- Collaborate with Research, Manufacturing, and Quality to ensure successful transfer of molecules, processes, and analytical methods, providing required technical support for investigations related to manufacturing and Quality.
- Operate cross-functionally to design and implement CMC strategies and regulatory submissions aligned with worldwide regulatory requirements and industry best practices.
- Prepare and manage complex CMC development plans, budgets, and long-range planning.
- 15+ years of proven experience in the pharmaceutical industry with a track record of developing and commercializing products, along with 10+ years in a supervisory role managing internal/external CMC staff.
- PhD in pharmaceutics, chemical engineering, organic chemistry, or a related field.
- Prior experience in development and manufacturing of peptides is preferred.
Rx Group is a clinical-stage biopharmaceutical organization headquartered in Cambridge, Massachusetts. The VP Pharmaceutical Development will report to the Chief Technical Operations Officer and will be responsible for providing strategic direction, technical leadership, and operational execution of CMC development activities in support of the company's clinical programs.