SummaryWe are seeking an Associate Director / Director, Project Management who will serve as a strategic project management partner for cross-functional drug development program (sub) team(s) and other key enterprise initiatives. The role is responsible for driving integrated planning, execution oversight, governance, risk management and decision support across complex projects as the company advances through Phase 3 development, NDA preparation and commercial launch readiness.
Working within the Project Management & Operational Excellence function, this individual will be embedded within program (sub) teams or strategic enterprise initiatives and will collaborate closely with leaders across Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Safety, CMC, Medical Affairs, Commercial, Quality and Corporate Functions. The successful candidate combines strong project and program management leadership skills with a pragmatic, hands-on approach and the ability to operate effectively in a dynamic environment.
Responsibilities- Serve as project manager for one or more development program (sub) teams or strategic corporate initiatives, driving execution against goals and proactively resolving issues that could impact delivery.
- Develop and maintain integrated cross-functional project plans with clear milestones, dependencies, assumptions and critical paths, ensuring objectives, deliverables and timelines are aligned across functions.
- Coordinate cross-functional readiness for Phase 3 execution, data readouts, NDA preparation, regulatory interactions and launch planning.
- Facilitate effective collaboration among internal teams and external partners.
- Run governance meetings, steering committees and leadership reviews, and maintain action, decision and risk logs.
- Prepare concise updates, dashboards, risk assessments and decision materials for senior management, escalating critical issues promptly to support informed decision-making.
- Identify, assess and monitor risks and opportunities, propose mitigation strategies, and support scenario planning and evaluation of strategic alternatives.
- Partner with functional leaders on resource requirements, constraints and trade-offs, ensuring the impact of changes in scope, timelines or assumptions is understood and communicated.
- Apply and continuously improve project management standards, tools, and governance, planning and reporting processes, including lessons learned, while avoiding unnecessary bureaucracy.
Required Qualifications & Experience- 8-12+ years of experience and Bachelor's degree in Life Sciences, Pharmacy, Medicine, Business or a related discipline. PMP or comparable qualification preferred.
- Strong knowledge of clinical development processes from Phase 1 through Phase 3 and major regulatory submissions (e.g. IND, NDA, MAA, BLA)..
- Strong command of integrated planning, critical-path analysis, scenario planning, risk management, governance, budgeting and lifecycle management.
- Proven leadership of complex global cross-functional teams, with the ability to influence without formal authority in a matrix environment, resolve conflict and manage senior stakeholders.
- Strong risk management and problem-solving capabilities.
- Demonstrated judgement, accountability and delivery focus while balancing speed, cost, quality and compliance.
- Excellent executive communication, facilitation, influencing and decision-support skills.
- Ability to operate effectively at both strategic and hands-on levels in a dynamic matrix organization.
