The
Vice President of Medical Affairs will build, develop, and lead our Medical Affairs function including Medical Science Liaisons, Medical Affairs Operations, Medical Information, Medical Communications, and Investigator Sponsored Trials for Orca-T (our lead, late-stage product), and other products in development as needed (responsibility shared with the Clinical R&D team for products in development).
You will lead the medical affairs team while working closely with the R&D team to support the publication and promulgation of clinical/pre-clinical data as well as other important information. You will present a strong outward-facing presence with key KOLs and will support the company in many different capacities, including business development. You will provide medical support for our trials in Advanced Hematologic Malignancies undergoing Allogeneic Hematopoietic Cell Transplantation.
Key Responsibilities- Reporting directly to the Chief Medical Officer (CMO), the VP of Medical Affairs, is accountable for the management, development, and execution of the Medical Affairs department-including the design and structure of the supporting functions of a Medical Affairs team such as Med Information, Medical Communications, Publications planning, Medical Science Liaisons, 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 Medical Affairs team.
- Working closely with the CMO, develop and lead 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.
- Lead and manage field facing Medical Science Liaison team.
- Working with the CMO, in developing the strategy for Medical Affairs including external communications, publications, investigator sponsored Trials (ISTs), congress and Advisory Boards planning and scientific communications.
- Lead publication planning and objectives 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.
- 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, including leading discussions around compassionate use programs
- Lead the medical objectives for Advisory Board meetings.
- Work closely with the 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 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 information to the relevant teams of the organization, as well as guidance to Commercial/Marketing Organizations on promotional material and campaigns.
Qualifications- Educational requirements: 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, from which minimum 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.
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
