Overview
Umoja Biopharma is a biotech start-up focused on transforming cancer treatment with a novel integrated immunotherapy platform. With locations in Seattle, WA and Louisville, CO, we pursue off-the-shelf therapies for treating tumors. We value diversity, equity, and inclusion and invite applications from individuals who share these commitments. We are seeking innovative thinkers excited by groundbreaking science and drug development to join our growing team.
Position Summary : The Medical Director will serve as a clinical leader, providing medical and scientific expertise to support the development of in vivo CAR-T therapy programs. This role involves clinical strategy, study design, execution, and regulatory interactions while partnering cross-functionally with R&D, Clinical Operations, Regulatory, and Program Leadership. The ideal candidate will have deep experience in cell & gene therapy and a strong track record in oncology or rheumatology clinical development. We will consider candidates at either the Director or Senior Director level based on qualifications and experience.
Responsibilities
- Provide medical leadership and clinical oversight for ongoing and planned in vivo CAR-T therapy programs.
- Contribute to the clinical development strategy, including indication selection, trial design, and endpoints.
- Serve as medical monitor for clinical studies, ensuring patient safety, data integrity, and compliance with GCP and regulatory requirements.
- Lead preparation of clinical protocols, investigator brochures, clinical sections of regulatory filings (IND, CTA, BLA), and other medical documents.
- Partner with Clinical Operations on trial execution, including site and investigator engagement, medical monitoring, and data review.
- Engage with global regulatory agencies to support program advancement.
- Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed.
- Collaborate with translational medicine, preclinical, and regulatory teams to align clinical strategy with scientific discoveries.
- Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology.
- Work with external program partners to deliver on contractual obligations while moving toward corporate goals and priorities.
The Successful Candidate Will Have
Director Level : MD, MD / PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. 2-5 years of clinical development experience, including at least 2 years in the biotechnology or pharmaceutical industry.Senior Director Level : MD, MD / PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. Minimum of 5 years of clinical development experience, including at least 4 years in the biotechnology or pharmaceutical industry.Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery is a plus.Direct experience in oncology clinical trial design, execution, and medical monitoring.Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies.Proven ability to interact with investigators, KOLs, and regulatory authorities.Excellent communication, leadership, and cross-functional collaboration skills.Passion for innovation and commitment to advancing transformative therapies for patients.Physical Requirements
Ability to travel at least 6x per year to site initiation visits, domestic and international conferences, ad boards, etc.Ability to work onsite at least 2 days / week.Salary Ranges : Director Salary Range : $250,000 - $313,000; Senior Director Salary Range : $270,000 - $333,000.
Benefits
Umoja Biopharma offers competitive Medical, Dental, and Vision plans. Additionally, employees have access to a 401k plan with a 100% match up to the first 4% of deferral. Umoja provides a generous Paid Time Off policy, commuter benefits, and a cell phone stipend. For a full breakdown of benefits, please see the Benefits section of our website.
EEO and Diversity Umoja Biopharma is committed to Diversity, Equity, and Inclusion and invites applicants from diverse backgrounds to apply.
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