Job Title: Program Manager, Operation Management
Location: Remote
Type: Min. 12 months contract w/extension possibilities (benefits offered)
Position Summary
- The Program Manager is the operational/tactical team leader for the Global Clinical Supply and Global Program Strategy Group (GCS/GPS) for one or more early or late-stage development asset(s).
- The PM provides global program management support to the Operations Asset Team(s) (OAT) in Global Operations, implementing industry-leading Program Management best-practices to align cross-functional stakeholders.
- The PM is responsible for development, management and tracking of the integrated program timeline, which includes the clinical supply execution plan and incorporates the deliverables across Global Operations, Quality, Reg Aff/Reg Aff-CMC and Process/Product Development.
- The PM facilitates, coordinates, and is responsible for the Program Execution Team and line-function sub-teams.
- The PM provides program level support to core functions in Global Clinical Supply (GCS), which includes, but is not limited to, the Operations Asset Leads (OALs), Clinical Manufacturing, Clinical Supply Management, and the Master Demand Planner(s).
- The Operations Management organization is specifically responsible for program timelines related to Global Operations and CMC functions, program reporting, meeting planning, integration support, Program Execution Team meetings, meeting minutes, action items/follow-ups, agendas, and other PM-related functions.
Principal Responsibilities
- Partner with the OAL(s) to develop and maintain program plans. Ensure tactical program deliverables align to overall program strategy.
- Facilitates and documents cross-functional team meetings to ensure on time delivery of product supply and key program regulatory CMC milestones.
- May represent GCS/GPSOM on indication or route-of-administration specific Global Program Teams (GPTs).
- Enables clinical supply execution and operational excellence by implementing program management tools (timelines, minutes, agendas, risk management, etc) and practices to ensure delivery of supply and regulatory filings.
- Drives execution of the program to achieve goals/objectives without compromising program deliverables or quality.
- Proactively manages the program critical path, assesses operational feasibility of strategic plans, and identifies and manages program risk.
- Manages the program schedule, budget, and resource information to enable efficient and effective CMC portfolio management.
- Leads operational program management for GO on all alliance co-development programs, including contributing roles on alliance sub-committees and steering committees.
- Responsible for development and management of the communication plan and stakeholder management plans.
- Coordinate portfolio reporting/metrics including status/risk dashboards and supporting technology
- Defines and aligns program communications (internal and external) with the Operations Asset Leader and team. Ensure effective, accurate and timely communication of team recommendations/escalations to governance bodies as needed.
- Manage a team with a diverse array of talents and responsibilities. Work closely with cross-functional teams to plan and develop scope, deliverables, required resources, work plan, budget, and timing for programs.
- Implement and manage changes to ensure program goals are achieved.
Qualifications
- 5+ years of related experience in biopharmaceutical industry/project management.
- Excellent organizational skills with attention to detail coupled with strong interpersonal skills, self-awareness and ability to manage team dynamics.
- Professional and effective written and oral communication skills.
- Demonstrated success in leading and negotiating in a matrix-based organization.
- Demonstrated ability to identify key program risks and develop mitigation strategies and contingency plans.
- Strong track record in program management in cross-functional drug development teams and/or clinical, regulatory, pharmaceutical sciences/technical operations team(s) in the biopharmaceutical industry.
- Excellent knowledge of program management discipline and its application to drug development.
- Demonstrated results in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and fiscal awareness.
- Knowledge of clinical & commercial manufacturing and distribution issues that impact program/product strategy and planning.
- Demonstrated ability to facilitate program team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
- Proficiency in core Microsoft software products (e.g., Excel, Word, PowerPoint, and Project). Experience with MS Project online preferred.
Education
- Bachelors' degree in business or scientific discipline required. Advanced degree and/or PMP Certification preferred.
