• Provide CMC operational leadership, tactical oversight, and guidance to program teams and management to support global program development.
• Work with the CMC Lead and cross-functional area experts to develop CMC strategies and design development work or studies.
• Manage the integration of defined CMC activities within CMC sub-teams and with the overall program development teams. Operationalize the CMC strategy and keep the team aligned.
• Build detailed CMC timelines with clarity to assumptions, risks and decision points.
• Support CMC area objectives, budgets and resource plans. Manage the CMC budget for programs through collaboration with consultants, contractors, and internal associates.
• Work with CMC functional leads to review strategies and manage tactical execution. Link discrete CMC strategies into a single, comprehensive strategy across the areas of drug substance, drug product, analytical, clinical supply chain, regulatory and quality.
• Establish and lead cross-functional CMC teams for assigned programs. Provide technical project management including Gantt and budget development, critical path analysis and risk mitigation.
• Partner with CMC leads to define the global CMC requirements (and their timing) to meet proposed clinical development plans and international product registration submissions.
• Support preparation of RFPs and assess technical capabilities for vendor selection; may support technical audits of CMC vendors, as well as oversight and management of contracted CMC activities.
• B.S. with 8+ years or M.S. with 5+ years of relevant experience as a CMC project manager and/or pharmaceutical functional area scientist.
• Proven leadership and cross-functional management of CMC projects, including demonstrated leadership in more than one CMC specialty, and extensive experience with vendor management.
• Flexible work schedule to accommodate program priorities and international activities as needed.
• Travel (some international) may be required.
• Ability to collaborate and influence team members, leaders across the company, and contract development manufacturing organization (CDMO) team members.
• Ability to run multiple cross-functional teams at one time to support the CMC portfolio.
• In-depth knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and cGMPs.
• Working knowledge CMC development strategies across IND-NDA stages and of global requirements for IND and NDA submissions (or their regional equivalents).
• Experience in preparation and submission of CMC documents in support of regulatory filings.