500 River Ridge Drive Second Floor
Job Category: Clinical: Regulatory
Job Number: 2201
The Senior Manager/Associate Director CMC Project Management will be responsible for operational leadership of cross-functional CMC project sub-team(s). S/he will ensure that the CMC project(s) are defined and implemented per the defined strategy and work closely with the CMC Technical Lead and the CMC Regulatory Lead to build, implement and execute the CMC project strategy and plans. S/he will work with internal and external stakeholders to define, manage and interpret results for CMC-related activities in support of global clinical development and registration. S/he will coordinate with the Project Leader to ensure coordination of company cross functional projects.
- 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.
REQUIREMENTS / QUALIFICATIONS:
- B.S. with 8+ years or M.S. with 5+ years of relevant experience as a pharmaceutical industry project manager and/or pharmaceutical functional area scientist.
- Proven leadership and cross-functional management of CMC projects, including demonstrated technical knowledge in more than one CMC specialty, and extensive experience with vendor management.
- Excellent oral and written and active listening communication skills.
- Command of working with project management programs such as MS Project®
- 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 projects at one time to support the CMC portfolio.
- Demonstrated knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and c-GMPs.
- Working knowledge CMC development strategies across pre-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 a plus.
- Project Management certification (PMP) a plus.