Medical Director

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 late-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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Summary: Unique opportunity! We are seeking a Medical Director to serve as medical lead for our early-stage clinical programs (pre-phase 3), including Investigator-Sponsored Trials (ISTs) and ongoing phase 1/2 trials, across multiple disease indications. This role is critical in developing, managing, and overseeing clinical trial protocols, ensuring smooth enrollment processes, and engaging with clinical sites to advance our pipeline. 

Additional Responsibilities

• Develop and write clinical trial protocols and other documents for early stage trials.
• Meet with clinical sites to generate interest and secure participation in trials.
• Medical monitoring, review, and analysis.
• Shepherd protocols through regulatory paperwork and approval processes.
• Oversee project timelines, ensuring all milestones are met.
• Provide leadership to a Clinical Trial Manager (CTM) and Clinical Research Associate (CRA) dedicated to early stage programs.
• Work closely with all relevant internal stakeholders; report into CMO and CSO.

Qualifications

• MD, PhD or PharmD required.
• 3+ years of industry experience and expertise in cell therapy or bone marrow transplantation (BMT) required, including with early-stage trials.
• 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, and occasionally to headquarters (Menlo Park, CA).