Vice President, Medical Affairs

Job description

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 commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. **Summary of Position:** TheVice 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 - 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 C-Suite, 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. - Manage the leader of the field-facing Medical Science Liaison function, with overall accountability for the team. - Working with the C-Suite, 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: M.D., Ph.D., or PharmD; MD degree preferred. - Minimum of 15 years of Medical Affairs or clinical research experience, from which minimum 5 years in Medical Affairs within Allogeneic Hematopoietic Cell Transplantation. - Minimum of 8 years’ experience in leading a Medical Affairs function; prior experience with new product launch. - Previous Medical Affairs expertise within hematology and/or transplant experience (specific diseases include AML, ALL, MDS) a must. - Previous cell therapy experience is highly desirable. - Track record of success in building and leading teams in small biotech settings. - 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.