Medical Director / Senior Medical Director, Clinical Development
Orca Bio
Summary
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.
Job description
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.
Requirements
- 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
- Experience implementing randomized registrational studies
- Self starter with an entrepreneurial mindset
- Strong project management skills
- Excellent verbal and written communication skills
- Willingness to travel as needed
Benefits
- Pre-IPO equity
- Annual bonus
- Medical, Dental & Vision
- PTO
- 401(k) plan
- Life insurance
- Accidental death and disability coverage
- Parental leave
- Subsidized daily lunches
- Snacks
Company overview
Orca Bio is a late-stage biotechnology company headquartered in Menlo Park, California, specializing in the development of high-precision cell therapies for the treatment of blood cancers and autoimmune diseases. Founded in 2016, the company focuses on creating allogeneic T-cell immunotherapies designed to replace a patient's diseased blood and immune system with a healthy one. Their proprietary manufacturing platform utilizes single-cell precision to develop uniquely-defined cell therapy products that aim to revolutionize the field of allogeneic cell therapy. Orca Bio's lead investigational product, Orca-T, is currently in advanced clinical development for hematological malignancies including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and myelodysplastic syndrome (MDS). The company employs a team of leading scientists, engineers, and clinicians who are united in their mission to transform patient lives through innovative cell therapy approaches that offer the promise of a cure without compromise.