Director - CMC

In this Director-level role, responsibilities include: Define and implement global CMC regulatory strategies for the development and registration of innovative drugs and biologics. Contribute to the development of the activity, both by growing the existing projects, and by generating/taking charge of new projects. Support the Head of Activity with the overall management of the function. Work transversally with other CMC and QA experts and across other VCLS units to bridge activities and ensure seamless collaboration and integrated client projects.

Chemistry, Manufacturing, and Controls (CMC)

• Lead/Participate in the definition and implementation of CMC regulatory strategies for small molecules, biologics, and/or cell & gene therapies across multiple therapeutic areas for the development and registration of innovative drugs.
• Provide advice on operational and technical CMC subjects (manufacturing, analytical development, validation, specification setting, stability, etc.).
• Lead/Provide support for the preparation of Agency meetings (EU and US).
• Lead/Participate in due diligence/gap analysis.
• Direct interactions with global regulatory authorities; lead meetings and support CMC regulatory activities.
• Remain current with CMC EU and US trends and requirements.
• Manage CMC regulatory risks and potential based on global regulations and guidance.

Project Management/Realization

• Direct/execute the prescribed activities for client projects, adhering to strategy, timelines, and milestones.
• Project management and keeping track of timelines/deliverables using project management tools.
• Timely internal and external communications and updates.
• Utilize consulting insight in the development of project scopes, plans, and deliverables gaining the confidence of both internal stakeholders and external clients.
• Overall management and oversight of internal resources including recruitment needs, to ensure adequate project allocation and delivery of quality services to clients.
• Manage existing client relationships effectively, maximizing all revenue opportunities, foster business development, and contribute to the development of proposals for new projects.
• Oversee budget negotiation process, forecasting, and finalization with key contractors.

Pre-Project/Business Development Activities

• Pre-project tasks (incl. drafting of proposals, participation in RFPs and scoping calls, meetings or teleconferences with prospects, etc.).
• Develop client portfolios (identification of new clients, development of existing ones) and participate in BusDev activities as per Activity/Product BD plan and in close relationship with regional BD team and Heads.

Strategy/Subject Matter Expertise

• Define the development strategy for the activity line.
• Notify/present/discuss Strategic Advisory Board relevant information regarding emerging areas of development and/or potential new services.
• Thought leadership: Present at company events, domestic/international conferences/webinars, and/or write articles in the area of expertise.
• Supervise team members, providing coaching, performance feedback, and career development.

Requirements

The ideal candidate will possess the following qualifications:

• Local to our Cambridge office (preferred), or
• Remote work if based outside the Cambridge area

Experience

• In-depth knowledge of CMC Regulatory Sciences as demonstrated through a combination of work experience and academic background
• Prior leadership experience in pharma, biotech, or related life sciences industry
• Prior leadership experience with regulatory submissions and interactions with the FDA and other regulatory agencies preferred
• Prior experience directly interacting with the FDA/Health Authorities is a plus
• Strong understanding of the drug development process
• Experience in a consulting environment is a plus
• BS/BA in Regulatory Affairs or Life Sciences; MS/MA and Ph.D. are a plus
• Certification: RAC is a plus

Personal attributes and skills

• Leadership and supervisory skills.
• Strong writing and communication (written and verbal) skills.
• Strong attention to detail, organization/multitasking, project management (planning, scheduling, documentation, project control), and teamwork skills.
• Consulting skills: influencing, advising, facilitating, diplomacy, critical thinking, adaptability, and presenting
• Problem-solving abilities a