Vice President, Medical Affairs

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary:
The Vice President of Medical Affairs will report to our Chief Medical Officer. You will build, develop, and lead our newly formed 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 lead registrational trial, Precision-T, a randomized phase III trial of patients with Advanced Hematologic Malignancies undergoing Allogeneic Hematopoietic Cell Transplantation with either Orca-T, a T-cell-Depleted Graft with additional infusion of Conventional T cells and Regulatory T cells, or Standard-of-Care Allogeneic Graft.

Key Responsibilities

• 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.

Qualifications

• Educational requirements: Advanced life science degree, including M.D., Ph.D., N.P, and/or Pharm.D.
• 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).
• Minimum of 5 years’ experience in leading a Medical Affairs function; prior experience with new product