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 experienceand 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.
$225,000 - $325,000 a year
The anticipated annual salary range (listed above) 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.
