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.
What they're looking for
- Bachelor’s degree required, advanced degree in life sciences strongly preferred
- 10+ years of relevant work experience required, including 8+ years in regulatory affairs
- Experience supervising, managing and coaching others strongly preferred
- Thorough working knowledge of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
- Exceptional influencing, partnership, and collaboration skills , including demonstrated ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Excellent written and verbal communication and collaboration skills
More about this role
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
- Developing and implementing regulatory strategy for complex development programs, leading project teams in implementing and delivering the regulatory strategy across multiple programs/indications and/or programs of increasing complexity
- Participating in cross-functional teams to provide regulatory feedback and support, proactively assessing and communicating potential risks and mitigation opportunities
- Overseeing and directly leading global Health Authority interactions, independently executing preparation,...
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