Director, Program Management

Overview

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large. The Program Director will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure. The Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).

External US

Job Title: Director, Program Management

Reports to: Head of Program Management

Employment Type: Full-Time

FLSA Status: Exempt

Summary: The Program Director will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure. The Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).

Essential Functions:

• Onboard new customer programs with the Sales Team to transition to become the primary liaison for program planning and execution upon confirmation that a Verbal Win/ Letter of Intent has been reached.
• Lead the planning and execution of programs in alignment with the FDBC-Program Management business best practice (vision, mission, SWOT/SIPOC, strategy-goals-objectives).
• Oversee the general day-to-day execution of project activities and planning to ensure on time completion of project tasks and deliverables as scheduled.
• Identify program delivery risks and mitigations and ensure program team, site leadership team, and customer are appropriately informed.
• Direct and mentor at least one Program Coordinator to accomplish goals agreed upon with the Head of Program Management, consistent with PMO and best practice procedures, to delight our customers.
• Process annual reviews, provide goals, guide and discipline direct reports.
• Lead the program team in Stage Gate reviews as part of the program life cycle to communicate program readiness and risk profile to the site leadership team.
• Establish daily Tier meetings to support communication structure for escalations and feedback in program risk items.
• Serve as the lead with the functional areas to ensure the SOW elements are accurate, complete, and organized based on revenue-generating segments of work.
• Ensure financial activities and program milestones are aligned (SOW, PPS, revenue recognition milestones, change orders, invoicing/payment activities, etc.).
• Ensure all Contract elements (BSA-MSA, Quality Agreement, Price and Payment Schedule, SOW) are completed.
• Develop and maintain the Master Project Plan (MPP) including ensuring durations and accountabilities for all revenue generating milestones are accurate through the scope of the program (contract sign, PD US/DS, AD, Tech transfer, Clinical-Commercial Manufacturing, QA, QC, Release, Ship Deliverables, Transfer in and Transfer out).
• Collaborate with the Sales Team to identify additional opportunities for additional work within the current contract.
• Partner with functional teams (QC, QA, PD, Manufacturing, etc.) to ensure that MPP revenue generating milestones are accurately translated into functional deliverables and all action items are completed per the committed timeline.
• Work closely with Process Development, Manufacturing, Engineering, Quality Control and Quality Assurance to reduce time to clinic or market, improve ease of manufacturing, and reduce costs when compared with existing platform products while achieving and maintaining full compliance (cGMP, Safety and Environmental).
• Accurately define timelines and resource requirements for the assigned projects.
• Maintain project documentation (change orders, project reports, timelines, etc.).
• Manage and lead program team meetings including issuance of agenda, action items, meeting minutes, client communications, etc.
• Communicate project updates to the Executive Team at predefined milestones and at defined