Job Description

Senior Director, CMC Program Leader - Permanent - Massachusetts, US

Proclinical is seeking an experienced Senior Director - CMC Program Leader to join a dedicated team within a pharmaceutical company.

Primary Responsibilities:

This role will be the primary liaison for all CMC project communications, building strong relationships with internal teams and external partners. The successful candidate's focus will be on ensuring project timelines and contracts are accurate, supporting CMC activities, and collaborating with cross-functional teams to deliver projects on time and within budget.

Skills & Requirements:

• Experience in the pharmaceutical industry, with a focus on small molecule development programs.
• Project management leadership experience, ideally with PMP certification.
• Expertise in coordinating CDMO activities for pharmaceutical product development and commercialization.
• Strong decision-making, communication, and resource management skills across geographically dispersed teams.
• Strong organizational and project management skills with a detail-oriented leadership approach.
• Knowledge of the drug development process, including key disciplines involved (CMC, non-clinical, clinical, regulatory filings, etc.).
• Understanding of cGMP requirements for pharmaceutical products.
• Demonstrated personal drive, goal-oriented decision-making, and self-motivation.
• Proven organizational and prioritization skills to manage diverse workloads effectively.
• Ability to work independently, cross-functionally, and collaboratively within a team setting.

The Senior Director - CMC Program Leader 's responsibilities will be:

• Act as the primary liaison for all CMC project communications with internal teams and external partners.
• Participate in regular teleconferences with CDMOs, document progress, and manage meeting notes and action items.
• Ensure accuracy in project timelines and contracts, addressing discrepancies with contractors or internal personnel.
• Support CMC activities by tracking relevant GMP and regulatory documentation.
• Collaborate with cross-functional teams to ensure timely, budget-compliant project delivery.
• Identify resource constraints, risks, and conflicts that may affect team bandwidth or company timelines.
• Manage project management responsibilities, such as shipment/logistics coordination and creating detailed project plans.
• Lead the creation and management of comprehensive and integrated development plans for CMC projects.
• Ensure project objectives are met according to program strategy, focusing on critical milestones and scope management.
• Promote collaboration across CMC functional teams, ensuring alignment on project goals and priorities.
• Regularly communicate project updates to stakeholders, covering strategies, adjustments, and progress.
• Utilize project management tools and best practices to facilitate CMC activities effectively.
• Exhibit excellent attention to detail, communication, time management, and organizational skills.
• Thrive in a fast-paced, small-company environment, managing multiple projects and rapidly changing information.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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