The Associate Director/Director, Clinical Development Program Management is a senior leadership role responsible for driving the strategic and operational execution of one or more clinical development programs from early- through late-stage trials. This individual will serve as a central point of accountability for cross-functional program delivery, a primary partner for Core Team and workstream Program Owners for Lyell’s asset(s). As part of this partnership, the Program Manager ensure priorities are met by understanding the clinical development process and status across the matrix team structure. S/he identifies potential obstacles, identifying options and solutions in partnership with the Program Owner. This individual works closely with Core Team Leads, Clinical Development, CMC, Regulatory Affairs, Biometrics, Quality, Pharmacovigilance, and external partners (CROs/vendors) to ensure trials and programs are delivered on time, within budget, and in compliance with GCP and applicable regulatory requirements.

This role requires a proven track record of leading complex, matrixed teams supporting Clinical Trials through approval and life cycle management. This individual translates clinical strategy into actionable operational plans, and anticipates and works to mitigate risk across the development lifecycle — including, where applicable, contributing to regulatory submissions supporting marketing approval (e.g., BLA/NDA).

Key Responsibilities

Strategic Program Leadership

• Serve as the clinical program manager for one or more development programs, partnering with Core Team Leads and Clinical Development leadership to translate clinical strategy into integrated, executable project plans.
• Support cross-functional Program/Sub-Teams, driving alignment on scope, timelines, budget, and risk across Clinical Operations, CMC, Regulatory, Biometrics/Data Management, Quality, Pharmacovigilance, Medical Affairs, and Finance.
• Partner with Core Team Leads to ensure clinical program plans are integrated with the broader development plan, including IND/BLA milestones, manufacturing readiness, and commercial launch timelines.
• Proactively identify program-level risks, dependencies, and resource constraints; develop and drive mitigation strategies and contingency plans in real time.

Cross-Functional & Matrix Team Management

• Lead, motivate, and hold accountable cross-functional strategic and tactical study/program teams, ensuring clear ownership of deliverables across internal stakeholders and external partners.
• Facilitate effective governance by running team meetings and leadership updates with clear agendas, decision logs, and action tracking.
• Manage team dynamics in a matrixed organization; work closely with functional leaders to resolve conflicting priorities and drive consensus among stakeholders without direct authority.
• Mentor and provide guidance to associate/senior clinical project managers and clinical operations staff, as applicable.

Operational & Tactical Execution

• Develop and maintain integrated project timelines and resource plans across all phases of clinical development (Phase 1 through Phase 3/registrational trials).
• Own the end-to-end project management infrastructure for assigned programs: timeline development, critical path analysis, forecasting (including long-range planning), vendor and CRO oversight, and risk registers.
• Ensure program documentation (project plans, meeting minutes, risk logs, status reports) is current, audit-ready, and inspection-ready.

Regulatory Submission Support

• Partner with Regulatory Affairs to align clinical deliverables (CSRs, protocol amendments, datasets, pre-submission meetings) with submission-critical timelines (e.g., BLA, NDA, MAA),
• Support clinical development deliverables for pre-submission meetings, briefing document preparation, and health authority interactions as needed from a project management/planning perspective.

Reporting, Tools & Continuous Improvement

• Develop and deliver clear, concise status reports and executive-level updates on program health, timelines, risks, and budget for senior leadership and governance bodies.
• Champion the adoption and effective use of project management tools and systems (e.g., Smartsheet, MS Project, or equivalent) to standardize planning, tracking, and reporting across programs.
• Identify opportunities to leverage AI-enabled tools and emerging technologies to improve forecasting, risk identification, resource planning, and reporting efficiency.
• Contribute to continuous improvement of clinical project management processes, templates, and best practices across the organization.

Required Qualifications

• Associate Director -
  • Bachelor's degree in a scientific, healthcare, or related discipline required; advanced degree (MS, PharmD, PhD) preferred. Minimum of 8 years of experience in clinical project/program management within the biopharmaceutical or biotechnology industry, spanning early-stage (Phase 1/2) and/or late-stage (Phase 3) drug development.
• Director -
  • Bachelor's degree in a scientific, healthcare, or related discipline required; advanced degree (MS, PharmD, PhD) preferred. Minimum 10 years of experience in clinical project/program management within the biopharmaceutical or biotechnology industry, spanning early-stage (Phase 1/2) and/or late-stage (Phase 3) drug development.
• Demonstrated experience leading and managing cross-functional strategic and tactical teams in a matrixed environment, with strong accountability for team performance and delivery.
• Deep understanding of the end-to-end drug development process, GCP/ICH guidelines, and clinical trial operations.
• Experience contributing to regulatory submissions supporting marketing approval (BLA/NDA/MAA), including submission planning, readiness tracking, and cross-functional coordination.
• Experience in cell therapy, immuno-oncology, or oncology drug development.
• Strong executive presence with the ability to communicate complex program status, risks, and trade-offs clearly and concisely to senior leadership.
• Proven ability to manage multiple, competing priorities in a fast-paced, evolving environment.
• Excellent organizational, analytical, negotiation, and problem-solving skills.

Preferred Qualifications

• Familiarity with AI-enabled project management or forecasting tools.
• Hands-on experience using Smartsheet (or similar tools, e.g., MS Project, Asana, Monday.com) for project planning, tracking, and reporting.
• PMP certification or equivalent formal project management training.