Director, PM Systems & Infrastructure
Listed on 2026-09-24
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Business
Change Management
Position Summary
The Director, Program Management Systems & Infrastructure owns the design of how program managers across pharmaceutical development actually work — the stage-gate models, governance templates, and cross-functional workflows they follow — and ensures those processes are adopted in practice, not just documented. This is a hybrid role spanning business process design and training/change management, built on the premise that a process nobody is trained on and doesn't change their behavior isn't a process at all — it's a document.
This person will partner closely with practicing PMs, R&D functional leads (clinical, regulatory, CMC, nonclinical), and the PM Systems & Infrastructure team to translate development-program complexity into workflows people can actually follow, and then drive the organizational adoption required to make those workflows stick.
- Own and continuously improve the stage-gate model, decision criteria, and governance cadence used by Program Managers across development programs
- Design and standardize processes related to core PM systems: including governance, risk registers, decision logs, integrated timeline templates
- Facilitate cross-functional process design sessions with clinical, regulatory, CMC, and nonclinical stakeholders to ensure PM system workflows reflect real dependencies, not idealized ones
- Identify process and system gaps and inconsistencies across programs/therapeutic areas and lead root-cause analysis when governance breaks down (e.g., late escalations, misaligned timelines)
- Maintain a living library of SOPs, playbooks, and process documentation, ensuring version control and regulatory-audit readiness where applicable
- Design and deliver onboarding curricula for new program managers, covering both tools and the underlying system governance philosophy
- Build job aids, quick-reference guides, and role-based training paths for PMs at different experience levels
- Lead change management for every process or system rollout: stakeholder impact assessment, communication plans, training delivery, adoption tracking, and feedback loops
- Establish and chair a practitioner steering group (working PMs, not just leadership) to pressure-test new processes before wide release
- Track adoption metrics (e.g., template usage, governance deck compliance, training completion) and report on process health to leadership
- Represent PM process and enablement needs in the broader PM Systems & Infrastructure roadmap, alongside dashboarding/tooling counterparts
- Act as the primary escalation point when new systems or reporting requirements (from IT, Quality, or Regulatory) require a change to PM-facing process
- 8–12+ years of experience in pharmaceutical/biotech drug development, including significant time as a program manager or in a PMO/R&D operations role
- Demonstrated experience designing or overhauling governance processes (stage-gates, decision frameworks, risk management) in a regulated drug development environment
- Direct experience building and delivering training programs or leading organizational change initiatives — this cannot be purely theoretical; the candidate should be able to speak to specific rollouts they drove and what adoption looked like before and after
- Strong facilitation skills; comfortable running cross-functional working sessions with senior stakeholders from clinical, regulatory, CMC, and finance
- Working knowledge of common PM tools in pharma (e.g., MS Project, Smartsheet, Planisware) — deep technical administration is not required, but fluency in how these tools support governance is
- Excellent written…
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