Vice President, Medical Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• The Vice President of Medical Affairs will report directly to the Chief Medical Officer (CMO) and is responsible for overseeing the management, development, and execution of the Medical Affairs department. This includes designing and structuring the support functions of a Medical Affairs team, such as Medical Information, Medical Communications, Publications planning, and Medical Science Liaisons, while effectively allocating internal resources and utilizing outsourcing to meet project and business objectives in a timely manner.

• Provide scientific and functional guidance to the Medical Affairs team.

• Collaborate closely with the CMO to develop and drive outreach initiatives by establishing and maintaining robust relationships with key opinion leaders, academic institutions, and medical societies in the hematology/oncology sector, particularly in cell therapy.

• Lead and manage the field-facing Medical Science Liaison team.

• Work alongside the CMO to formulate the strategy for Medical Affairs, which includes external communications, publications, investigator-sponsored trials (ISTs), congress and Advisory Boards planning, and scientific communications.

• Oversee publication planning, objectives, CME education, symposia, and congress planning, while evaluating all Medical Communication requirements to support product launch.

• Evaluate and implement Medical Information requirements to facilitate launch support.

• Manage the review process for investigator-initiated studies following product launch.

• Develop policies and procedures for essential Medical Affairs activities, ensuring adherence to the principles of Scientific Engagement, including leading discussions surrounding compassionate use programs.

• Direct the medical objectives for Advisory Board meetings.

• Collaborate closely with Regulatory Affairs and Commercial teams to ensure timely, accurate, and compliant preparation and review of promotional and educational materials.

• Partner with Legal and Compliance to guarantee that Medical Affairs activities are conducted in line with Orca’s policies and procedures, while also complying with all pertinent laws and regulations.

• Work in close collaboration with cross-functional teams, including Clinical Development, Clinical Operations, Project Management, Regulatory Affairs, and Commercial, to ensure the successful development and commercialization of Orca-T.

• Provide medical and scientific insights to relevant internal teams, as well as guidance to Commercial/Marketing Organizations regarding promotional materials and campaigns.

⛳️ Requirements

• Educational qualifications: An advanced life science degree, which may include an M.D., Ph.D., and/or Pharm.D., with preference for an MD degree.

• A minimum of 15 years of experience in medical affairs or clinical research, including at least 10 years specifically in Medical Affairs within the pharmaceutical or biotech sectors.

• At least 8 years of experience leading a Medical Affairs function; previous experience with new product launches is highly preferred.

• Previous expertise in Medical Affairs within hematology and/or transplant, particularly in specific diseases such as AML, ALL, and MDS, is strongly preferred.

• Prior experience in cell therapy is highly desirable.

• Proven track record of success in building and leading teams.

• A collaborative Medical leader capable of establishing and fostering strong cross-functional partnerships and scientific exchanges with a variety of stakeholders.

• Experience in the US healthcare marketplace is mandatory.

• This position requires extensive travel, up to 50% of the time.

• Ability to maintain confidentiality and operate with the highest ethical standards and professionalism.

🏝️ Benefits

• Competitive medical, dental, and vision benefits

• PTO

• 401(k) plan

• Life and accidental death and disability coverage

• Parental leave benefits

• Subsidized daily lunches and snacks at on-site locations