Department:
106600 Clinical Operations
Location:
San Diego, USA- Remote
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
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.
Working in close partnership with Clinical Operations and Clinical Pharmacology leaders, overall program project managers, Regulatory, Research, and Program/Product Teams, the Associate Director will identify and accelerate rate-limiting activities while preserving scientific quality, patient safety, compliance, and decision quality. The successful candidate combines strong drug-development judgment with advanced Smartsheet capability, disciplined project controls, and the ability to influence outcomes in a matrixed environment.
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.
Provide concise dashboards, milestone forecasts, critical-path analyses, and status updates to functional leaders, program governance teams, and executive stakeholders.
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.
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.
Additional duties assigned as needed.
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.
Project Management Professional (PMP) certification or comparable formal project-management training is preferred.
Additional Skills/Experience:
The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
Driven, intelligent, passionate about making a difference for patients with rare diseases.
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.
