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About the Role

Denali Therapeutics is seeking a leader to organize and manage CMC strategies, deliverables, and timelines for the company's programs, including oversight of contract manufacturing organizations. This role ensures timely decision-making across the CMC portfolio from research through commercial phases, integrating CMC deliverables into overall project timelines.

Responsibilities

• Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research through all later phases of development, including pivotal studies and regulatory submissions.
• Manage CRO/CMO vendor selection and serve as a point of contact for outsourced CMC projects and large-scale material production.
• Facilitate, manage, and lead internal CMC project teams.
• Establish and maintain CMC project timelines and budgets, tracking deliverables and ensuring integration into overall project plans.
• Proactively outline risks and mitigations, communicating them to relevant teams and senior management.
• Provide regular updates to senior management on project status, timelines, risks, and forecasting.
• Collaborate with technical leaders, Program Directors, and cross-functional teams to develop and execute drug development strategies.

Requirements

• Typically requires a BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline, with 12+ years of relevant biotech/pharmaceutical/CMO CMC experience, or a Master’s degree with 10+ years of experience.
• An advanced degree and CMC Experience with novel constructs (e.g. bi-specifics, enzyme fusions) is preferred.
• Experience managing CMC activities at CROs/CMOs required.
• Drug Substance and Drug Product GMP experience required.
• Command of project management practices and software.
• Thorough understanding of the overall drug development process.
• Excellent leadership, interpersonal skills and demonstrated ability to build effective working relationships and partnerships with internal team members and collaborators at CROs/CMOs.
• Experience in effectively working through high-pressure situations; excellent conflict management skills.
• Drive to take ownership and responsibility in ensuring the success of the projects and deliverables.
• Results- and detail-oriented.

Skills

• Project management practices and software
• Drug development process
• Leadership
• Interpersonal skills
• Conflict management

Location

• Remote

Work Type

• Full-time

Experience Level

• 10+ years
• 12+ years

Education Level

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline
• Master’s degree

Salary/Compensations

• $159,000.00 to $207,000.00

Benefits

• 401k
• Healthcare coverage
• ESPP

About the Company

• Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through its 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.

Equal Opportunity

• 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.