The Director/Associate Director, Project Management (CMC) is responsible to ensure adherence to the project scope, timeline and budget, and intervenes when necessary to identify and resolve issues in order to ensure timely completion of the CMC development process. This position involves relationships with a key CMO for FG and as such, requires enhanced communication and organizational skills. This position works across all programs at FG and concentrates on the CMC aspects of each program.
1. Work with key CMOs on the following:
- Initiation/planning activities
- monitoring and tracking of budget against scope of work and key deliverables
- Direct interface with CMO
- FTE tracking, invoice tracking, signatures
- projections/forecast FTEs
- risk management
- Conflict escalation/issues resolution
2. Support Supply Chain with invoice follow up and serve as key communication link between clinical and supply chain groups
3. Manages the creation and maintenance of multi-disciplinary CMC project plans.
4. Evaluates CMC program timelines and finds innovative alternative scenarios and contingency/mitigation plans.
5. Prepares timelines for, and monitors and tracks all assigned action items and sub teams, with clear focus on critical path issues and Go/No-Go decisions.
6. Demonstrates a clear understanding of drug/biologic development and issues affecting the CMC development process.
7. Communicates with key personnel and interacts with stakeholders regarding relevant information associated with each assigned project.
8. Disseminates CMC project information/timelines to other functional project team members in a timely manner and style that fosters teamwork and communication.
9. Assures that all CMC departments have clear direction and deadlines for deliverables.
10. Writes and provides periodic updates for management highlighting progress, obstacles and any remedial action proposed and taken.
11. Supports multi-disciplinary project teams to strategically and expeditiously create and execute CMC development plans.
12. Coordinate/plan major activities necessary to complete CMC sections for regulatory submissions/applications.
13. Acts as multi-disciplinary liaison and one-stop-shop for CMC project information and cross functional alignment.
14. Demonstrate superior knowledge and tactical implementation of PM best practices and serve as source of information on those practices for CMC sub project teams.
15. Assists project teams with annual budgeting process and tracking and reporting on project team budgets ($ and FTEs) for CMC.
1. 8-10 Years experience as a CMC project manager in the biotech or pharmaceutical settings
2. Partnership experience or direct experience managing CMOs
3. Either small molecule or biologics experience, both a plus
4. Ph.D. or MBA preferred, PMP a plus
5. Excellent organizational and communication skills
6. Outstanding interpersonal skills and be regarded as possessing strong leadership qualities while at the same time being able to adapt style to situation.
7. MS Project, Excel, Word, Visio, MS Project Server
8. Experience using MS Project to analyze resource demand