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It continues to be an exciting time for BlueRock Therapeutics as the company advances a pipeline of cutting-edge cellular therapies to positively impact patients’ lives.
In this newly created and highly visible role reporting to the Head of Development, the Head of Medical Affairs will have the unique opportunity to build a team of internally and externally facing professionals to support BlueRock’s advancing and expanding clinical pipeline of authentic cell therapies. The position will be based in Cambridge, MA.
Responsibilities:
- Create and implement a Vision for BlueRock’s Medical Affairs & Scientific Communications
- Build and provide leadership to key Medical Affairs sub-functions including Field Medical Affairs and Scientific Communications.
- Provide oversight of, and content-expertise to, outsourced functions such as Medical Information and HEOR.
- Support the writing and updating of SOPs for Medical Affairs, ensuring compliance with all relevant external guidelines.
- Collaborate with cross-functional teams to drive brand strategy, ensure alignment across teams, and provide compliant medical input.
- Ensure the development and execution of strategic and functional plans and facilitate processes to ensure all Medical Affairs programs and activities are aligned with business strategies and regulatory guidelines.
- Establish compliant thought leader engagement strategies and plans to ensure an integrated approach across field medical affairs and with internal teams.
- Develop the Scientific Communications department in charge of delivering impactful scientific and medical education for internal and external stakeholders including publication and congress plans and material development.
- Develop BlueRock's HEOR capabilities by developing appropriate medical materials and supportive documents and by providing medical expertise as required.
- When appropriate, represent Company at external meetings with stakeholders, in accordance with the developed medical strategies,
- Lead strategic and engagement activities with national and international advocacy organizations
- Lead data gap identification, data dissemination and active insight collecting.
- Facilitate key processes including grant review and IIT review committees.
- Create a continuous learning environment that encourages internal team engagement and strong external partnerships.
- Work with Regulatory Affairs to design and implement any post-approval clinical studies (including registries).
- Identify key areas of need for medical education programs and develop standard answers to program and procedures through content-driven educational programming and medical responses for urgent clinician questions regarding patient care.
- Support business development efforts through the delivery of medical insights.
- Conduct secondary research and present data on product/disease areas of interest as needed.
- Serve as a key medical resource for the disease areas and specific products as part of business development activities.
- Throughout all activities, maintain the highest level of sensitivity, integrity, and compliance.
Minimum Requirements:
- MD required
- Background in Neurology and/or Ophthalmology strongly desired.
- Minimum of 15 years of experience in Medical Affairs, including in developing medical engagement strategies
- Successful product launches in the US, ex-US experience is helpful.
- Experience or demonstrated understanding of clinical development and research
- Direct interactions or demonstrated understanding of engaging with payer organizations, health technology assessors, and/or regulatory agencies.
- Experience with the medical publications process
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