Denali Therapeutics brings the power of biotherapeutics to the whole body, including the brain. We discover, develop and deliver medicines for people living with serious diseases. Backed by GV.
About the role
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor's degree in a life science or related field required, advanced degree in life sciences (PhD, PharmD, MD, or MS) strongly preferred
- Demonstrated success leading global regulatory strategy across a multi-program portfolio, including direct leadership of FDA and EMA interactions and at least one marketing application (BLA/MAA) through approval
- Proven ability to lead through ambiguity and translate scientific, clinical, and cross-therapeutic-area insight into practical, defensible regulatory strategy
- Strong executive presence and communication skills, with demonstrated success presenting regulatory strategy and risk to boards, executive committees, and Health Authorities
- Deep familiarity with FDA, including current review division trends, policy direction, and ways of working, and the ability to anticipate how these will shape rare disease development and approval
- Familiarity with the use of AI tools for research, regulatory intelligence, and strategy development, and openness to adopting new technologies and ways of working
More about this role
Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This role leads clinical regulatory strategy across Denali's rare disease development portfolio, from IND/CTA through marketing application and lifecycle management, ensuring program-level regulatory strategies are scientifically rigorous, globally coherent, and aligned with the function-wide strategy set by the Head of Global Regulatory & Clinical QA. It serves as the senior regulatory strategist and primary Health Authority interface for these programs, leads a team of...
Browse similar: Startup jobs · San Francisco Bay Area