Associate Director, CMC Program Mgmt

Denali Therapeutics; South San Francisco (CA); On-site; USD 159,000 - 207,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Scorpion Therapeutics in South San Francisco, CA, is seeking a senior CMC lead to organize, manage, and drive CMC strategies for drug candidates from research through NDA submissions. You will coordinate CRO/CMO vendors, lead internal CMC teams, and ensure timelines and budgets are integrated into program plans.

The role requires a BA/BS with 12+ years in biotech/pharma CMC, advanced degree preferred, GMP experience, and strong leadership.

Qualifications

• BA/BS in Science/Math/Engineering or related field with 12+ years biotech/pharma/CMO CMC experience (or Master’s with 10+ years).
• Advanced degree and CMC experience with novel constructs preferred.
• Experience managing CMC activities at CROs/CMOs required.

Responsibilities

• Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research, pre-IND, and first-in-human through later phases, including pivotal Phase 2/3 and NDA/MAA/BLA submissions.
• Manage CRO/CMO vendor selection; serve as point of contact for outsourced CMC projects and early-stage biotherapeutics requiring large-scale material production.
• Facilitate, manage, and lead internal CMC project teams.
• Establish and maintain CMC project timelines and budgets; track deliverables and ensure integration into overall project plans.
• Proactively outline risks and mitigations; communicate risks/issues to CMC, project teams, and senior management.
• Provide regular updates to senior management on status, timelines, risks, and future CMC needs.
• Collaborate with technical leaders, Program Directors, and cross-functional teams to develop and execute drug development strategies and plans.

Skills

CMC program leadership

Vendor management

GMP experience

Project management software

Drug development knowledge

Leadership

Conflict management

Ownership mindset

Education

BA/BS in Science/Math/Engineering

Master’s degree in related field

Tools

GMP compliance knowledge

Job description

Key Accountabilities/Core Job Responsibilities:

• Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from research, pre-IND, and first-in-human through later phases, including pivotal Phase 2/3 and NDA/MAA/BLA submissions.
• Manage CRO/CMO vendor selection; serve as point of contact for outsourced CMC projects and early-stage biotherapeutics requiring large-scale material production.
• Facilitate, manage, and lead internal CMC project teams.
• Establish and maintain CMC project timelines and budgets; track deliverables and ensure integration into overall project plans.
• Proactively outline risks and mitigations; communicate risks/issues to CMC, project teams, and senior management.
• Provide regular updates to senior management on status, timelines, risks, and future CMC needs.
• Collaborate with technical leaders, Program Directors, and cross-functional teams to develop and execute drug development strategies and plans.

Qualifications/Skills:

• BA/BS in Science/Math/Engineering or related field with 12+ years relevant biotech/pharma/CMO CMC experience (or Master’s with 10+ years).
• Advanced degree and CMC experience with novel constructs (e.g., bi-specifics, enzyme fusions) 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 drug development process.
• Excellent leadership/interpersonal skills; ability to build relationships with internal teams and CRO/CMO collaborators.
• Strong conflict management; effective under high pressure.
• Ownership mindset; results- and detail-oriented.

Compensation/Benefits:

• Salary range: $159,000–$207,000.
• Competitive total rewards package including 401k, healthcare coverage, and ESPP.