Greater New York City Area, United States of America
Chief Medical Officer | International Biotech, NJ/NY Metro area
Reporting directly to the CEO, the Chief Medical Officer will serve as the interface, medical/strategic expert, and cross-functional team leader for R&D, Translational Medicine, Early Clinical Development, and eventually Late-Stage Clinical Development and Commercialization. In addition, you will serve as a key executive decision-maker for compound/portfolio assessment (go/no-go), BD & Licensing, Strategic Partnering, etc. Our client is an international start-up and, as such, is looking for a hands-on executive who isn’t afraid to “get in the weeds” and understands/appreciates the opportunity that sweat equity can offer.
Responsibilities
- Serve as the interface and medical/cross-functional leader across R&D, Translational Medicine, Clinical Development and eventual Late-Stage Clinical Development and Commercialization.
- Provide clinical development and operational excellence/expertise to the design, implementation and execution across all clinical programs in development (development plans, protocols, timelines, budgets/resources, etc.).
- Develop program-wide risk-benefit profile assessments and lead go/no-go discussions within the organization for R&D and Clinical Development.
- Interact effectively with worldwide regulatory authorities, scientific experts/key opinion leaders, academic alliances and media.
- Ensure medical integrity and strategy across all Drug Safety/Pharmacovigilance/Risk Management activities while closely coordinating these efforts with the development team.
- Medical and strategic input into Business Development & Licensing and Strategic Partnering assessments.
Qualifications / Requirements
- MD/PhD or MD and Board Certification is required.
- Medical expertise within Cell Therapy, Oncology, Immuno-Oncology and/or Immunology is required.
- Minimum of 15 years of experience in Biotech/Pharma drug development and/or clinical research, including experience leading a BLA submission for a new biologic is required.
- Minimum of 5 years of experience working for an international company(s).
- Proven track record of R&D and clinical leadership and personnel management.
- Experience in product registration/submission and major Health Authority interaction is required.
- Experience in Medical Affairs/Commercial is greatly preferred.
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