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Medical Director, Clinical Development
Orca Bio
Data Science
Remote
Posted on Jul 25, 2024
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 Orca Q program, including the ongoing phase 1 trial and Investigator-Sponsored Trials (ISTs), which span multiple disease indications. This role is critical in developing the protocol, analyzing data, conducting the clinical trial. The candidate must work collaborative within Orca Bio and also with PIs nationwide to progress the program towards product registration.
Location: Menlo Park, CA preferred.
Responsibilities
- Support strategic planning and execution of clinical strategy.
- Develop clinical trial protocols, statistical analysis plans, investigator brochures, and other documentation for early stage trials.
- Develop and present CRO/CRA/site training materials and present at Investigator Meetings/site initiation visits as required.
- Provide leadership to a Clinical Trial Manager (CTM) and Clinical Research Associate (CRA) dedicated to early stage programs.
- Medical monitoring, review, and analysis
- Interpret early stage clinical data and provide an ongoing assessment of pre-clinical, clinical, scientific literature to inform clinical strategy and ensure positive benefit-risk profile for assigned programs in collaboration with key stakeholders.
- Collaborate with Regulatory, Operations, Safety, Medical team to provide oversight, prepare reports, and ensure all milestones are met.
- Work collaboratively with all internal and external stakeholders.
Qualifications
- MD, PhD or PharmD required.
- 3+ years of industry experience and expertise in cell therapy, bone marrow transplantation (BMT), or immune disorder preferred, 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).
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
To learn more: https://orcabio.com/join-our-team/
**all official communication will be from @orcabio.com; please beware of scams**
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.