Associate Director, Project Management - Clinical

Position Summary

The Associate Director, Project Management is responsible for departmental planning and timeline governance across Clinical Operations and Clinical Pharmacology. This role builds and maintains high-quality functional timelines, connects those plans to integrated program schedules, and provides clear visibility to milestones, dependencies, risks, and decisions.

Responsibilities

• Own, develop, and maintain departmental timelines for Clinical Operations and Clinical Pharmacology across multiple studies and development programs, from early planning through key regulatory and clinical milestones.
• Build and administer scalable Smartsheet solutions, including integrated schedules, cross-sheet dependencies, reports, dashboards, automated workflows, baselines, and portfolio-level views that support timely, accurate decision-making.
• Translate functional strategies into executable plans with clear activities, durations, owners, milestones, assumptions, predecessor/successor logic, and critical-path visibility.
• Partner with overall program project managers to incorporate functional plans into integrated program timelines and maintain alignment with program strategy, governance decisions, and corporate priorities.
• Integrate Clinical Operations milestones such as study start-up, site activation, enrollment, data review, database lock, and clinical study reporting and Clinical Pharmacology deliverables such as bioanalysis, PK/PD analyses, modeling and simulation, dose rationale, and clinical pharmacology reports with overall Program timelines.
• Work cross-functionally with Regulatory, Research, Clinical Development, Biometrics, Medical Writing, and Program/Product Teams to map interdependencies, sequence handoffs, and build coherent end-to-end timelines.
• Identify rate-limiting steps and emerging schedule constraints; lead scenario planning, schedule compression, and recovery planning; and drive agreement on practical acceleration options, tradeoffs, and decision points.
• Facilitate timeline reviews and cross-functional planning sessions, constructively challenge assumptions and commitments, confirm accountability, and maintain clear action and decision records.
• Establish and maintain integrated risk, issue, action, and decision tracking; escalate material threats early with impact assessment, options, recommendations, and accountable owners.
• Support planning for regulatory interactions and submissions by ensuring that relevant clinical operations and clinical pharmacology activities, dependencies, reviews, and approvals are reflected in the integrated plan.
• Cross-coordinate internal and external partner timelines, including CROs, laboratories, modeling vendors, and other service providers, and ensure vendor deliverables remain aligned with program milestones.
• Develop and implement consistent project-management standards, templates, naming conventions, quality checks, change-control practices, and reporting cadences for departmental timeline management.
• Contribute to functional capacity and resource planning by highlighting timing conflicts, competing priorities, cross-program dependencies, and potential execution bottlenecks.
• Champion a collaborative, accountable, and patient-focused operating culture that converts strategy into measurable execution.

Education/Experience Requirements

• Bachelor’s degree in life sciences, pharmacy, business, project management, or related discipline required. Advanced degree preferred.
• Equivalent combination of education and applicable job experience may be considered.
• 8+ years of relevant experience in the biotechnology or pharmaceutical industry required, including at least 4 years of direct project-management experience supporting R&D or clinical development activities in Biotech or Pharmaceutical industry.
• Demonstrated experience planning and managing complex, cross-functional, multi-study, or global development timelines from strategy through execution.
• Direct project-management experience supporting Clinical Operations and working knowledge of Clinical Pharmacology activities and deliverables. Experience supporting both functions is strongly preferred.
• Experience integrating functional timelines with broader program plans and supporting governance, regulatory milestones, or major clinical-development decisions.
• Advanced Smartsheet capability, including complex project plans, dependencies, cross-sheet formulas, reports, dashboards, automated alerts and approvals, standardized templates, and portfolio roll-ups.
• Ability to establish practical governance and data-quality controls is required.
• Strong understanding of drug-development planning and the interdependencies among Clinical Operations, Clinical Pharmacology, Regulatory, Research, Biometrics, Medical Writing, and program governance.
• Working knowledge of clinical-development processes and terminology, including study start-up and conduct, vendor deliverables, data-review milestones, PK/PD, bioanalysis, modeling and simulation, and regulatory submission planning.
• Demonstrated ability to analyze critical paths, model scenarios, pressure-test assumptions, and create credible acceleration or recovery plans without obscuring risk.
• Excellent facilitation, negotiation, and influencing skills, with the confidence to drive clarity, ownership, and timely decisions across a matrixed organization.
• Executive-ready written and verbal communication skills, including the ability to distill complex schedules, tradeoffs, and risks for audiences at all organizational levels.
• Strong attention to detail, sound judgment, and the ability to manage ambiguity, shifting priorities, and multiple concurrent programs in a fast-paced environment.
• Proficiency with Microsoft Project, Excel, PowerPoint, Teams, SharePoint, and document-management systems is preferred.
• Self-directed and accountable, with a consistent record of following through on commitments while fostering productive cross-functional relationships.
• Ability to travel 10% domestic and internationally.