Reporting to the Senior Vice President, Program Management, the Associate Director, Program Management will provide leadership for, and oversight of, Kiniksa’s evolving product portfolio and will have responsibility for leading the preclinical stage program team(s) into successful clinical development phases by ensuring execution and delivery of program results including financial accountability. The Associate Director, Program Management will also be responsible for alliance management of acquired and in-licensed assets including partner relationship management. Emphasis will be on superior leadership, execution and transparency across the organization and to Senior Management.
Under the direction from, and in collaboration with the Senior Vice President of Program Management, the Associate Director, Program Management will:
- Lead and support detailed integrated program plan build and resource plan creation for early clinical stage program(s) including high-level strategy planning through BLA/MAA approvals.
- Lead a high performing program team by setting clear priorities and expectations for team and team member’s roles and responsibilities, promoting team cohesiveness to optimize performance.
- Leverage input from all critical functions to prepare integrated development plan(s) that maximize the value of the program(s).
- Collaborate with functional program leads to prepare program(s) costs and integrating the program(s) into the corporate budget and forecasting process.
- Provide hands-on support to cross-functional teams charged with overseeing specific tasks and stages of program development.
- In collaboration with the program team, assesses risk(s) and develops mitigation and contingency plans for successfully completing the program objectives and deliverables on-time.
- Collaborates with research program management to align on discovery program plans for monitoring and communicating program transitions from research into development phases.
- Monitors program progress, cost, resource allocation, timelines and collaborates with functional team leads to proactively identify risks and resolve issues.
- Collaborates with program management team to develop reports and metrics for communicating program status to inform all levels in the organization (Executive, Management, Program Team).
- Communicates with external program stakeholders to ensure that corporate objectives for each program are met.
Education and Experience:
- Bachelor’s degree in business or scientific discipline.
- Master’s degree preferred in business or scientific discipline.
- A minimum of 7-8 years of experience in program management in life sciences (biotech and/or pharmaceutical) managing cross functional teams in early stage program development (late stage program development is a plus).
- Biologics experience strongly preferred.
- Functional experience in project management (ie: clinical operations, CMC) a plus.
- Hands on experience managing large, transformational programs.
- Extensive background in developing and managing project/program management processes, techniques and tools.
- Experience in facilitating change, including collaboration with senior-level stakeholders.
- Proven internal and external influencing skills at senior management levels.
- PMP certification a plus.
- Solid experience in the execution and operational management of early stage drug development programs.
- Demonstrated experience in leading teams through successful first-time IND submissions (and Ph1 strategy planning) leading to IND clearance with FDA (and EU submission(s) equivalent, is a plus).
- Phase 2 and Phase 3 clinical stage program management experience
- BLA/MAA program management experience a plus.
- Excellent team building, leadership and management skills.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of high-quality work at all times.
- Direct and motivate with influence.