SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies for blood cancer patients, aiming to improve survival rates and reduce risks associated with traditional allogeneic stem cell transplants. The company is seeking a Medical Director or Senior Medical Director to lead clinical development for Orca-Q, a late-stage cell therapy program.
In this role, you will serve as the medical lead for a pivotal Phase 3 study, responsible for conceptualizing the study design, developing clinical protocols, and conducting the trial. You will work collaboratively across Orca Bio's internal teams and with primary investigators nationwide to advance the program toward product registration.
Key responsibilities include:
- Supporting strategic planning and execution of clinical strategy
- Developing clinical trial protocols, statistical analysis plans, investigator brochures, and regulatory documentation
- Creating and presenting CRA/site training materials and leading Investigator Meetings and site initiation visits
- Providing leadership to Clinical Trial Managers, Clinical Research Associates, and Clinical Scientists dedicated to the program
- Conducting medical monitoring, review, and data analysis
- Interpreting early- and late-stage clinical data and assessing preclinical and clinical literature to inform strategy and ensure positive benefit-risk profiles
- Collaborating with Regulatory, Operations, Drug Safety, and other teams to ensure oversight and milestone achievement
- Engaging with all internal and external stakeholders to drive program success
The role offers the opportunity to shape a pivotal late-stage development program at a company with a strong mission-driven culture and entrepreneurial spirit.
REQUIREMENTS:
- MD required; preferably trained in bone marrow transplant (BMT), hematology, and/or oncology
- 3+ years of industry experience with expertise in cell therapy, BMT, or immune disorders preferred
- Experience implementing randomized registrational studies
- Self-starter with entrepreneurial mindset
- Strong project management skills; ability to handle multiple priorities and timelines, work independently, and drive initiatives
- Excellent verbal and written communication skills; ability to engage and motivate clinical site teams
- Willingness to travel as needed to meet with clinical sites and stakeholders
