Medical Director / Senior Medical Director, Clinical Development

Orca Bio•Menlo Park, CA

2d•$225,000 - $325,000

About The Position

Orca Bio is seeking a Medical Director or Senior Medical Director, depending on experience, to serve as the medical lead for the late-stage Orca-Q next-generation cell therapy program. The role will contribute to conceptualizing the pivotal Phase 3 study, developing its protocols, analyzing data, and conducting the clinical trial. The medical lead will work collaboratively across Orca Bio and with primary investigators nationwide to advance the program toward product registration.

Requirements

MD required.
Strong project management skills, including the ability to manage 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.

Nice To Haves

Training as a bone marrow transplant physician, hematologist, and/or oncologist preferred.
Three or more years of industry experience and expertise in cell therapy, bone marrow transplantation, or immune disorders preferred, including experience implementing randomized registrational studies.
Self-starter with an entrepreneurial mindset.

Responsibilities

Support strategic planning and execution of clinical strategy.
Develop clinical trial protocols, statistical analysis plans, investigator brochures, and other clinical-trial documentation.
Develop and present CRA and site training materials, and present at Investigator Meetings and site initiation visits as required.
Provide leadership to the Clinical Trial Manager, Clinical Research Associates, and Clinical Scientists dedicated to the program.
Conduct medical monitoring, review, and analysis.
Interpret early- and late-stage clinical data and assess preclinical, clinical, and scientific literature to inform clinical strategy and help ensure a positive benefit-risk profile, in collaboration with key stakeholders.
Collaborate with Regulatory, Operations, Drug Safety, Medical, and other teams to provide oversight, prepare reports, and ensure milestones are met.
Work collaboratively with internal and external stakeholders.