Full-Time

Director – CMC Program Leader

Denali Therapeutics

Denali Therapeutics

201-500 employees

Develops therapies for neurodegenerative diseases

Biotechnology

$204,000 - $245,333

Includes a competitive total rewards package, 401k, healthcare coverage, ESPP, and a broad range of other benefits.

Senior

San Bruno, CA, USA

Required Skills
Communications
Requirements
  • BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline
  • Experience with novel constructs (e.g. bi-specifics, enzyme fusions) strongly preferred
  • Extensive experience managing CMC activities at CROs/CMOs required
  • Ability to work effectively and collaboratively on cross-functional projects teams
  • Excellent communication, collaboration, and negotiating skills
  • Ability to travel to manage collaborations with CROs and CMOs
Responsibilities
  • Develop, lead and drive CMC strategies, plans, and deliverables for small molecule and/or biologic drug candidates
  • Lead CRO/CMO vendor selection process and serve as a point of contact for CROs and CMOs for outsourced development projects
  • Represent Denali in issue escalation and resolution with our CMOs/Vendors
  • Facilitate, manage, and lead internal CMC project teams
  • Establish and maintain CMC project timelines and budgets
  • proactively outline risk and mitigations and communicate risks and issues to CMC teams, project teams, and senior management
  • Provide regular updates to senior management on project status, timelines, risks, and forecasting for future CMC project needs
  • Collaborate with technical leaders, Program Directors, and cross-functional project teams

Denali Therapeutics stands out as a leader in the field of neurodegenerative diseases, leveraging recent scientific insights into genetic causes and biological processes to develop effective treatments for conditions like Alzheimer's, Parkinson's, and ALS. The company's culture is characterized by a commitment to rigorous science, translational medicine, and collaboration, fostering an environment where diverse backgrounds and experiences unite behind the shared goal of defeating degeneration. Denali's competitive advantage lies in its deep expertise in neurodegenerative disease biology and the blood-brain barrier, which informs a robust portfolio of programs at various stages of clinical and preclinical development, all aimed at improving patient lives by addressing disease causes or risk factors.

Company Stage

IPO

Total Funding

$1.1B

Headquarters

South San Francisco, California

Founded

2015

Growth & Insights
Headcount

6 month growth

-8%

1 year growth

-5%

2 year growth

7%
INACTIVE