Medical Director, Clinical Development

About the position

Outpace Bio is pioneering the future of cell therapy for solid tumors by harnessing unrivaled AI-powered protein design. Our mission is to program immune cells for enhanced function inside patients, overcoming key barriers such as poor tumor access, weak survival, antigen escape, and dose-related toxicity. By creating and integrating modular, plug-and-play technology assets, we are developing cell therapies with unprecedented efficacy, transforming how engineered T cells interact with cancer and the immune system to deliver life-changing outcomes. Our multidisciplinary team of scientists, engineers, coders, and cell therapy developers works at the cutting edge of computational protein design, synthetic biology, and immunology. Together, we are reimagining how cells function to unlock novel therapeutic possibilities. Located in Seattle's vibrant biotech hub overlooking scenic South Lake Union, Outpace Bio is led by pioneers in computational protein design and engineered cell therapies. Our culture is built on a foundation of respect and inclusion, which are fundamental to how we collaborate to revolutionize cell therapy through groundbreaking innovation rooted in rigorous science.

Responsibilities

• Provide strategic leadership and medical expertise for clinical development plans.
• Author protocols and informed consents and contribute to clinical study reports.
• Collaborate with clinical operations teams to support clinical studies.
• Partner with Regulatory to develop and support strategy for IND and BLA submissions.
• Ensure the safety of study participants through active participation in safety monitoring.
• Serve as the primary medical representative interfacing with regulatory agencies and key opinion leaders.
• Act as recognized clinical expert for assigned programs.
• Participate in due diligence activities and provide medical expertise in support of business development initiatives.

Requirements

• Must have an MD or MD/PhD with recent oncology-related clinical development experience.
• 3+ years of experience at a pharmaceutical or biotechnology company as a (Associate) Medical Director.
• Strong knowledge of the pharma/biotech industry and drug development process.
• Extensive understanding of medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines.
• Prior experience with cell therapy preferred.
• Experience leading health authority interactions with global regulatory agencies.
• Experience with interpretation of clinical research results including safety and efficacy.
• Ability to think strategically, innovatively, and tactically.
• Demonstrated ability to evaluate, interpret and present complex scientific data.
• Ability to adapt and problem-solve in a fast-paced, team-based environment.
• Excellent interpersonal, verbal, and written communication skills.

Nice-to-haves

• Familiarity with pharmacovigilance requirements and processes.
• Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.

Benefits

• Medical, dental, vision, life insurance, and disability coverage.
• Flexible spending account and 401k plan.
• Stock option grants and performance bonus.
• Flexible PTO and paid sick leave.
• Fifteen paid holidays plus a winter shutdown.
• Generous paid parental leave policy.