Vice President of CMC

Accountabilities: The Vice President of CMC will lead all Chemistry, Manufacturing, and Controls activities across clinical-stage programs, ensuring assets progress efficiently while maintaining quality, compliance, and strategic alignment. This role requires strong external partnership management, technical expertise, and the ability to make informed decisions in a fast-paced environment.

Own CMC strategy and execution across the full portfolio, including drug substance, drug product, analytics, stability, supply, GMP responsibilities, and regulatory submission content.

Ensure CMC activities remain on schedule and within budget while integrating manufacturing considerations into broader clinical development plans.

Lead selection, contracting, and ongoing management of CDMOs, testing laboratories, suppliers, consultants, and technical experts.

Assess inherited CMC packages during asset evaluation processes, identifying risks, gaps, timelines, costs, and opportunities before licensing decisions are made.

Provide CMC leadership for regulatory submissions, including authoring and overseeing Module 3 content for IND filings and supporting additional regulatory interactions.

Build and maintain a strong network of external CMC experts, consultants, and key opinion leaders to support program execution.

Guide manufacturing strategy decisions, including technology transfer, scale-up activities, comparability assessments, and clinical supply planning.

Partner with clinical, regulatory, and development teams to ensure CMC requirements are aligned with program goals and milestone expectations.

Operate with a high degree of autonomy, managing delivery through external resources rather than a large internal team.

Requirements:

The ideal candidate is a seasoned CMC leader with extensive pharmaceutical development experience, strong technical judgment, and the ability to operate effectively in an agile, high-growth environment.

10+ years of experience in CMC, pharmaceutical development, or related technical functions, including significant ownership of CMC activities for development programs.

Proven experience managing external manufacturing partners, including CDMOs, through clinical development, technology transfer, scale-up, and clinical supply activities.

Demonstrated ability to lead CMC sections of regulatory submissions, including IND submissions and ideally contributions to NDA, BLA, or major regulatory amendments.

Strong understanding of clinical-stage development, particularly Phase I and Phase II programs.

Experience across multiple therapeutic modalities, including small molecules and biologics, with the ability to quickly understand new technologies.

Experience evaluating and integrating CMC packages from external assets or third-party licensors.

Strong understanding of GMP requirements, manufacturing processes, quality considerations, and lifecycle management strategies.

Ability to assess risks, prioritize effectively, and determine appropriate levels of CMC investment based on program objectives.

Excellent stakeholder management, communication, and negotiation skills with the ability to influence internal and external partners.

Comfortable working independently, managing complex projects, and delivering results under tight timelines.

Entrepreneurial mindset with strong ownership, adaptability, and a passion for improving healthcare innovation.

Benefits:

Competitive compensation package with meaningful equity opportunities.

Fully remote work environment for candidates based in the United States or United Kingdom.

Flexible engagement structure, including full-time or contract/fractional arrangements.

Comprehensive health insurance coverage.

27 days of annual leave plus 11 national holidays.

Monthly wellness allowance to support health and wellbeing activities.

Enhanced parental leave benefits.

Annual learning and development budget for courses, certifications, and professional growth.

Access to employee discounts, wellness programs, and remote team benefits.

Opportunities to participate in company events, team gatherings, and charitable initiatives.

The opportunity to contribute to transforming healthcare development through innovative approaches to clinical-stage biopharma.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

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