Program Management - Drives development of the device goals in partnership with the Device lead that enables on-time filings and delivery of clinical supply for all phases of development. Monitors and reports on the progress of the program goals.
- Leads generation, alignment, and continual monitoring of an integrated program plan across functional lines involved in the development and delivery of supply/device.
- Provides key updates on program risks, progress and mitigation plan to management as needed.
- Drives execution of the device project to achieve delivery and performance goals/objectives without compromising project deliverables or relationships.
- Utilizes project management skills to drive projects to key decision points and milestones. Proactive management of the critical path, operational feasibility of strategic plans, active program risk management (risk registers, etc), and alignment of operational execution.
- Monitors/manages progress against the program schedule including acceleration, financial staging opportunities, and scenario planning. Partners with the team to identify contingency and risk mitigation strategies for project/program level plans
- Defines/aligns program messages and major communications (internal and external) with the Device Lead and CMC PMs as needed. Responsible for ensuring effective, accurate and timely communication of program information in order to facilitate development of options and team recommendations to governance.
Device Program Management - Creation and Management of Detailed Device Project Timeline:
- Create/Update/Maintain an overall detailed device project timeline and share overview
- Should be inclusive of cross functional activities that effect device development; ADMF, GSC, Clinical, external vendor activities etc.
- Scope including planning through design transfer/LCM activities
- Track team activities
- Provide/align on key device milestones w/ device TL for communication to overall CMC team and vendors as needed
- Responsible for adherence to project timeline and communication of status, progress, risks, deviations or delays to the appropriate stakeholders
- Drive/Enforce/Reinforce deadlines for completion of document reviews/approvals
- Following up with approvers/reviewers to complete tasks
- Confirms ownership of reviewers/approvers for docs are identified and system access/mitigation in place to meet project timelines
- Partner with Device Lead/SMEs to ensure alignment on team objectives, status, risks and communications:
- Provides clear communication of risks/issues to key stakeholders/facilitates meetings to define/mitigate risks as needed
- Maintains device risk/issues log and dashboards as needed
- Schedule/facilitate meetings including but not limited to Device CMC subteam, vendor meetings, design reviews etc
- Prepare agendas and provide clarity on meeting objectives, expectations and clear R&R for internal/external mtgs
- Record/distribute team meeting minutes in a timely manner
- Record Design Review meeting minutes/drive SME approves for stage gate closures
- Follow up with vendors on progress, risks etc to ensure adherence to project timelines
- Record/share meeting minutes with vendors
- Partner with vendor PM and Device TL to ensure consistent messaging to team
- Maintain device collaboration site - Share files from vendors with team, share files with vendor,
- Schedule/Lead formal documented project kickoff
- Understanding the overall cross functional process to assist overall project strategy and planning prior to kickoff of design controls
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Skills: | 5-15 years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or combination product/device PM. - Understands Design Control/Reviews and the five stages of device development
- Able to create a highly collaborative and inclusive environment necessary for the cross-functional device teams to be effective.
- Strong track record in executing effective program management skills in cross-functional matrix organizations.
- Excellent knowledge of program and project management discipline and its application to drug development to deliver time, cost, quality, and risk management to teams.
- Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
- Demonstrated ability to effectively implement the tools and techniques of the program and project management discipline, such as the development and management of multi-disciplinary program level integrated plans, critical path management, project risk management, decision analysis and meeting management.
- Proven track record of achievement and delivery of team goals.
- Knowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planning desirable.
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