Director, CMC Program Leader

The Opportunity

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.

Responsibilities

• Develop, lead and drive CMC strategies, plans, and deliverables for small molecule and/or biologic drug candidates from the research, pre-IND, and first-in- human testing phases to all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions

• 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. Track CMC deliverables and timelines and ensure the CMC strategies and plans are incorporated into the overall project plans

• 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

Qualifications

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline, with 10+ years of relevant biotech/pharmaceutical/CMO CMC experience. Advanced degree strongly preferred.

• Direct experience with biologics CMC required. Experience in late-stage development strongly preferred

• Experience with novel constructs (e.g. bi-specifics, enzyme fusions) strongly preferred

• Extensive experience managing CMC activities at CROs/CMOs required

• Extensive technical/functional/development expertise in Drug Substance, Drug Product, Drug Delivery, Analytical or Regulatory

• Drug Substance and Drug Product GMP experience required

• Responsible to lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement

• Command of project management practices and software

• Excellent 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.

• 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

Salary Range: $204,000.00 - $245,333.00. 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 https://www.denalitherapeutics.com/careers

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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