Senior Manager, Clinical Program Planning

Role Summary

The Clinical Project Planning Senior Manager provides strategic oversight and expert project management across the full lifecycle of clinical programs, ensuring alignment, efficiency, and delivery excellence across Clinical Affairs subfunctions, including Clinical Development Operations, Publications, HEOR, Pharmacovigilance, and Late-Stage Research. This role delivers expertise in project management, strategic initiative execution, and related systems and tools, enabling leadership to track program progress. A key accountability is to design and maintain tools and frameworks that provide transparent visibility into program timelines, risks, and critical path activities, bridging clinical and commercial planning functions to support data-driven decision-making.

Responsibilities

• Develop and maintain clinical program roadmaps, dashboards, and KPIs to provide leadership with visibility into progress, risks, and strategic opportunities.
• Support governance activities, including portfolio operational reviews and clinical executive meetings.
• Partner with clinical trial leads/ functional leads to ensure coordinated oversight of clinical studies/ program timelines from planning, start-up through close-out. Monitor and report milestones across all study phases (Phase 1-4), ensuring that dependencies and critical path activities are proactively managed.
• Identify and escalate operational risks and delays, ensuring timely mitigation and leadership awareness.
• Drive data-informed decision-making by providing accurate milestone and resource-tracking insights.
• Facilitate engagement forums that promote transparency, collaboration, and a culture of operational excellence.
• Design, implement, and oversee comprehensive tracking systems for all Clinical Affairs sub-functions.
• Integrate sub-functional plans into a unified portfolio with a view to enable data-driven portfolio management and performance tracking.
• Ensure all tools and trackers maintain inspection readiness and meet internal quality and compliance standards.
• Standardize processes and develop playbooks that drive efficiency, consistency, and scalability across programs.
• Apply project management methodologies (e.g., risk management, scenario planning, change control) to strengthen operational delivery.
• Lead or contribute to process improvement initiatives, promoting the adoption of digital PM tools (e.g., MS Project/ Project Online, Planisware, Smartsheet) and data visualization dashboards (Power BI, Tableau, Spotfire etc.).
• Collaborate with internal and external partners to ensure seamless cross-functional execution.
• Translate complex clinical and operational information into executive-level presentations, supporting strategic decision-making.

Qualifications

• Required: Bachelor’s degree in Life Sciences, Business, Engineering, or related field; advanced degree preferred.
• Required: Minimum of 6 years of progressive experience in clinical program management, clinical development or clinical operations within the biotechnology or pharmaceutical industry.
• Required: Proven track record in leading cross-functional clinical programs or strategic operations initiatives.
• Required: Demonstrated experience in managing end-to-end clinical program delivery, including clinical stage-gate planning, protocol development through CSR, regulatory submission, and publications, with proven expertise in timeline management, project planning, and milestone tracking across all clinical phases.
• Required: Strong background in developing project tracking systems, dashboards, or governance tools that enhance visibility and accountability.
• Required: Experience leading or mentoring cross-functional project teams and applying structured change management practices.
• Required: Travel up to 20% as needed.
• Preferred: PMP certification or equivalent project management training.
• Preferred: Lean Six Sigma Green or Black Belt certification.

Education

• Bachelor’s degree in Life Sciences, Business, Engineering, or related field required; advanced degree preferred.