Associate Director or Director Clinical Development Program Management

Key Responsibilities

• 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.
• 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.
• 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.