Head of Global Medical Affairs
3 weeks ago
The Head of Global Medical Affairs will provide strategic leadership to develop an integrated medical affairs strategy with a significant impact on Bicycle’s current and emerging programs. You will actively support clinical development activities, operating cross-functionally by engaging with the diverse teams across Bicycle including, but not limited to: Research, Clinical, Regulatory Affairs, Commercial, and other functions, to ensure that scientific and medical strategies are aligned with corporate and medical community needs. Key contributor to new product planning and pre-launch activities.
Develop the global Medical Affairs function, building and developing a global team (including a field MSL team) as we prepare for commercialization
Develop the Medical Affairs strategy and operational plan in a cross functional manner including contributions to Bicycle Corporate Goals
Lead internal data interpretation, analysis plans and communication strategy
Lead publication strategy and planning for Bicycle, define publication timelines, and review all publications (abstracts, manuscripts, posters, presentations, etc.) and ensure that they are consistent with the strategy
Responsible for, in conjunction with the Clinical Development team, ensuring the successful dissemination of innovative clinical information to thought leaders and foster medical and scientific information exchange
Work closely with healthcare practitioners and KOLs for their valuable input, organization/facilitation of advisory boards in coordination with clinical development
Proactively incorporate patients' & physicians' voice in the development of medical strategies & tactics
Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs
Develops and maintains positive professional relationships with thought-leaders based on mutual respect and the interest in sharing perspective on medical therapies. This includes obtaining feedback from the independent community of relevant healthcare professionals within Oncology globally
Management of investigator supported trials when programs are initiated
Strategic development of Medical Information content and services (including standard responses, FAQs and medical library), including the management and training of staff and/or vendors as we approach commercialization
Key contributor to new product development / planning and pre-launch activities
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Head of Product Development and Manufacturing
4 weeks ago
Cambridge, United States Volnay Therapeutics Full timeVolnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, developing, and implementing robust and scalable manufacturing processes for our cell...
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Cambridge, United States Volnay Therapeutics Full timeVolnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, developing, and implementing robust and scalable manufacturing processes for our cell...
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