Medical Director, Clinical Development

About Outpace Bio

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.

Our Commitment to Diversity

At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to cultivating an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.

Our Momentum

In August 2024, Outpace Bio secured an oversubscribed $144 million Series B financing, led by RA Capital Management and supported by a premier syndicate of life science investors. This funding accelerates our pipeline of programmed T cell therapies, including our lead candidate OPB-101, a mesothelin-specific chimeric antigen receptor (CAR) T cell enhanced by Outpace’s proprietary OUTSMART™, OUTLAST™, OUTSPACER™, and OUTSAFE™ technologies. OPB-101 is advancing toward IND clearance and first dosing in 2025 for patients with advanced platinum-resistant ovarian cancers. The Series B investment also supports the expansion of our pipeline, enabling us to develop additional transformative therapies leveraging our innovative plug-and-play technology platform.

To enable this vision, we are seeking a highly motivated and experienced Medical Director to help lead our cross-functional teams designing and advancing programmed T cell therapies into the clinic. Reporting to the Chief Development Officer, the Medical Director, Clinical Development will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on study and program-specific activities. The Medical Director, Clinical Development will drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will work on cross-functional program development and study management teams for the design, execution, and (medical) monitoring of clinical trials and assist with data interpretation. The Medical Director will be responsible for data communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department. We’re looking for a clinician who thrives in dynamic environments and is passionate about Outpace’s mission to revolutionize cell therapy. If you’re a medical oncologist and clinical development professional eager to work on cutting-edge science with a collaborative team and grow your career, this could be the role for you.

• Clinical Leadership: Provide strategic leadership and medical expertise. Support the design and execution of clinical development plans for Outpace’s cell therapy oncology programs, ensuring alignment with strategic objectives and timelines. Author protocols and informed consents and contribute to authoring of clinical study reports, training documents, and other clinical documents.
• Trial Execution and Management: Collaborate with clinical operations teams to support the conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities. Provide organizational support for Safety Review Committees and other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communicating key decisions.
• Cross-functional Collaboration: Work closely with cross-functional teams including Translational Sciences, Biometrics, Regulatory, and Clinical Operations to ensure integrated and strategic trial execution. 
• Regulatory: Partner with Regulatory to develop and support strategy for IND and BLA submissions. Provide scientific/medical content and other input as appropriate for INDs, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents and communication with US and international regulatory agencies as necessary.
• Medical Safety Monitoring and Data Review: Ensure the safety of study participants by actively participating in safety monitoring and data review processes. Accountable for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results for internal presentations, Safety Review Committees, external scientific publications and regulatory purposes.
• Stakeholder Engagement: Serve as the primary medical representative, interfacing with regulatory agencies, investigators, and key opinion leaders. Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives; respond to or triage questions for appropriate escalations.
• Company Representative: Act as recognized clinical expert for assigned programs both within and external to Outpace. Represent the company before appropriate scientific, medical, regulatory, business and other professional meetings and industry events.
• Other Business Activities: Participate in due diligence activities and provide medical expertise in support of business development initiatives.

• Must have an MD or MD/PhD with recent oncology-related clinical development experience: 3 years (for a board eligible or certified oncologist) or 5 years (if no formal oncology training) of experience at a pharmaceutical or biotechnology company as a (Associate) Medical Director.
• Strong knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process; extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations.
• Prior experience with cell therapy preferred.
• Experience leading health authority interactions with global regulatory agencies, prior BLA and NDA experience not required, but is a strong plus.
• Experience with interpretation of clinical research results including safety and efficacy required. Familiarity with pharmacovigilance requirements and processes and statistical principles desirable.
• Ability to think strategically, innovatively, and tactically with an interest in clinical research and drug development with a focus on delivering results and driving innovation.
• Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy. Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
• Ability to adapt and problem-solve in an agile, fast-paced, start-up, team-based matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
• Ability to handle multiple projects at a time and have strong attention to detail while understanding the higher-level strategy.
• Excellent interpersonal, verbal, and written communication skills, with the ability to effectively communicate complex medical and scientific information to diverse audiences; ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach.
• Effectively manage pressure and conflict while practicing inclusive leadership; possess strong negotiation skills and can effectively drive discussions and decisions toward desired end-results. Aptitude or proven ability to mentor colleagues and foster their successful career development; strong orientation to teamwork.
• Passion for developing complex, innovative medicines for solid tumors.

The salary range is based on Outpace Bio's reasonable estimate of base salary for this role at the time of posting. Actual base salary will be based on a variety of factors including skills, experience, and other related factors permitted by law.

Working at Outpace offers an exciting opportunity to contribute to groundbreaking research that has the potential to transform the lives of people around the world.

Outpace Bio Total Rewards

Full time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment and a performance bonus. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and fifteen paid holidays plus a winter shutdown. Outpace also offers a generous paid parental leave policy to all regular full-time employees.

Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.

Salary : $350,000 - $390,000