Vice President, Medical Affairs

Summary

Join Orca Bio, a late-stage biotechnology company, as the Vice President of Medical Affairs. Reporting to the Chief Medical Officer, you will build and lead the Medical Affairs function, encompassing Medical Science Liaisons, Medical Affairs Operations, Medical Information, Medical Communications, and Investigator Sponsored Trials. You will collaborate closely with R&D to support data publication and dissemination, engage with key opinion leaders, and provide medical support for the Precision-T trial. This role requires strong leadership, strategic planning, and cross-functional collaboration to drive successful product development and commercialization. Extensive travel is required.

Requirements

• Have an Advanced life science degree, including M.D., Ph.D., N.P, and/or Pharm.D
• Have a minimum of 12 years’ medical affairs or clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned)
• Have a minimum of 5 years’ experience in leading a Medical Affairs function
• Have experience in the US health care marketplace
• Be willing to travel extensively (up to 50%)

Responsibilities

• Be accountable for the leadership, development, and execution of the Medical Affairs Strategy—including the design and structure to support the necessary supporting functions of a Medical Affairs team such as Med Info, Med Com, Pub planning, MSLs, etc., allocating and directing internal resources while effectively utilizing outsourcing to achieve project and business goals in a timely manner
• Provide scientific and functional leadership to the future Medical Affairs team
• Develop and lead Key Opinion Leader outreach by establishing and maintaining strong relationships with key opinion leaders, academic institutions, and medical societies in the field of hematology/oncology, particularly cell therapy
• Assess sizing needs and implement a field facing MSL team
• Lead publication strategy and planning, CME education, symposia, and congress planning and assess full Medical Communication requirements to support launch
• Assess and implement Medical Information requirements to support launch
• Establish investigator-initiated studies program review process post-launch
• Establish policies and procedures for key Medical Affairs activities, ensuring compliance with the principles of Scientific Engagement, including leading discussions around compassionate use programs
• Lead the medical strategy for Advisory Board meetings
• Work closely with the Regulatory and Commercial organizations to ensure timely, accurate and compliant preparation and review of promotional and educational material
• Partner with Legal and Compliance to ensure Medical Affairs activities are conducted according to Orca’s policies and procedures, and in a manner compliant with all external laws and regulations
• Collaborate closely with cross-functional teams, including clinical development, clinical operations, project management, regulatory affairs, and commercial, to drive the successful development and commercialization of Orca-T
• Provide medical and scientific training to the rest of the organization, and as well as, guidance to Commercial/Marketing Organizations on promotional material and campaigns
• Help define and lead strategy as a senior member of the research and development organization and be a member of the Research and Development leadership team

Preferred Qualifications

• Have prior experience with new product launch
• Have previous Medical Affairs expertise within hematology and/or transplant experience (specific diseases include AML, ALL, MDS)
• Have previous cell therapy experience
• Have a track record of success in building and leading teams
• Be a Collaborative Medical leader who can establish and drive strong cross-functional partnerships and scientific exchange with diverse stakeholders