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.
Position Summary: Unique opportunity! We are seeking a Medical Director / Senior Medical Director (depending on experience) to serve as medical lead for our next-generation cell therapy program (Orca-Q) late-stage study. This role is critical in conceptualizing our Pivotal Phase 3 study, developing the associated protocols, analyzing data, and conducting the clinical trial. The candidate must work collaboratively within Orca Bio and also with primary investigators (PIs) nationwide to progress the program towards product registration.
Responsibilities
Support strategic planning and execution of clinical strategy.
Develop clinical trial protocols, statistical analysis plans, investigator brochures, and other documentation for clinical trials.
Develop and present CRA/site training materials and present at Investigator Meetings/site initiation visits as required.
Provide leadership to Clinical Trial Manager (CTM), Clinical Research Associates (CRA) and Clinical Scientists dedicated to the program.
Medical monitoring, review, and analysis.
Interpret early- and late-stage clinical data and continuously assess preclinical, clinical, and scientific literature to inform clinical strategy and ensure positive benefit-risk profile for assigned programs in collaboration with key stakeholders.
Collaborate with Regulatory, Operations, Drug Safety, Medical and other teams to provide oversight, prepare reports, and ensure all milestones are met.
Work collaboratively with all internal and external stakeholders.
Qualifications
MD required; preferably a trained bone marrow transplant (BMT) physician, hematologist and/or oncologist.
3+ years of industry experience and expertise in cell therapy, BMT, or immune disorders preferred, including experience implementing randomized registrational studies.
Self starter with an entrepreneurial mindset.
Strong project management skills, with the ability to handle multiple priorities and timelines, work independently and drive initiatives.
Excellent verbal and written communication skills, with the ability to engage and motivate clinical site teams.
Willingness to travel as needed to meet with clinical sites and stakeholders.
