Executive Director, Oligonucleotide and Small Molecule CMC

1 week ago

South San Francisco, California, United States Denali Therapeutics Full time
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.

This is an exciting opportunity to build and lead oligonucleotide and small molecule CMC capabilities and activities to support Denali's portfolio including the advancement of our novel oligonucleotide transport vehicle (OTV) therapeutics.


We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.


Responsibilities:

  • Develop, lead and drive strategies, plans, and deliverables for oligonucleotide and small molecule CMC activities for IND-enabling activities through all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions
  • Build and lead highly engaged and productive small molecule CMC team encompassing process chemistry, formulation and analytical development activities for Denali's small molecule programs and antisense oligonucleotides
  • Collaborate effectively with technical leaders and cross-functional project teams to address and solve challenges and complete CMC activities needed to advance programs
  • Manage activities within functional budgets and prioritize and communicate with senior management and project teams risks to complete activities within these budgets and request additional resources when necessary
  • Actively participate and contribute to Tech Ops Leadership team and at other leadership forums across Denali
  • Build productive relationships with key CMO and project partners to enable efficient execution of CMC deliverables
  • Consistently model and demonstrate Denali values

Requirements:

  • Ph.
D. in chemistry, engineering, or a related scientific discipline, with at least 10 years of relevant biotech/pharmaceutical/CMO CMC experience. B.S./M.S. with 15+ years of relevant experience would also be considered

  • Direct experience with oligonucleotide and small molecule CMC development required, and experience with taking projects through NDA filing to approval highly desired
  • Significant experience managing CMC activities at CMOs required
  • Demonstrated ability to build and lead effective teams, including recruiting & hiring as well as subsequent employee development
  • Excellent leadership, interpersonal skills and demonstrated ability to build effective working relationships and partnerships with internal team members and collaborators at CMOs
  • Proven track record in delivering high quality, impactful results which enable successful progression of clinical programs

Salary Range:
$272,000 to $ Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at


This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment.

We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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