Vice President, Medical Affairs

About the role

The Vice President of Medical Affairs will lead the Medical Affairs function at Orca Bio, a biotechnology company focused on developing next-generation cell therapies for blood cancer treatment. This role includes managing Medical Science Liaisons, Medical Affairs Operations, Medical Information, Medical Communications, and Investigator Sponsored Trials for Orca-T, the company's lead late-stage product.

Responsibilities

• Build, develop, and lead the Medical Affairs function
• Manage, develop, and execute the Medical Affairs department
• Design and structure supporting functions of a Medical Affairs team
• Allocate and direct internal resources while utilizing outsourcing
• Provide scientific and functional leadership to the Medical Affairs team
• Work closely with the CMO to establish and maintain relationships with key opinion leaders, academic institutions, and medical societies
• Lead and manage the field-facing Medical Science Liaison team
• Develop the strategy for Medical Affairs, including external communications, publications, investigator-sponsored trials (ISTs), congress planning, and scientific communications
• Lead publication planning and objectives, CME education, symposia, and congress planning, and assess full Medical Communication requirements to support launch
• Assess and implement Medical Information requirements to support launch
• Manage the 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
• Lead the medical objectives for Advisory Board meetings
• Collaborate with Regulatory Affairs 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 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 information to relevant teams of the organization, as well as guidance to Commercial/Marketing Organizations on promotional material and campaigns

Qualifications

• Advanced life science degree, including M.D., Ph.D., and/or Pharm.D. (MD degree preferred)
• Minimum of 15 years of medical affairs or clinical research experience, with at least 10 years in Medical Affairs within the pharmaceutical/biotech industry
• Minimum of 8 years’ experience in leading a Medical Affairs function; prior experience with new product launch is strongly preferred
• Previous Medical Affairs expertise within hematology and/or transplant experience (specific diseases include AML, ALL, MDS) strongly preferred
• Previous cell therapy experience is highly desirable
• Track record of success in building and leading teams
• Collaborative Medical leader who can establish and drive strong cross-functional partnerships and scientific exchange with diverse stakeholders
• Experience in the US health care marketplace is required
• Extensive travel is required as part of this position (up to 50%)
• Ability to maintain confidentiality and to operate with the highest ethical standards and professionalism