Associate Director, Clinical Project Management

Crinetics PharmaceuticalsHeadquarters, KY
Onsite

About The Position

The Associate Director, Clinical Project Management is responsible for oversight of Clinical Project Management activities for multiple studies and molecules, including timeline, risk, and budget management for all clinical trials managed by Clinical Operations. This role involves developing, maintaining, and managing high-quality study processes and templates, providing clinical program timeline and budget estimates, and overseeing a team of Clinical Project Managers. The position also requires developing and overseeing policies and procedures to streamline Clinical Project Management, providing input on annual planning, and acting as a Subject Matter Expert for clinical timelines and budgets. Routine status reporting, including study timeline and budget dashboards, is also a key responsibility. The role collaborates with finance to oversee monthly accrual processes, ensure accuracy of cost accruals, and review accrued costs against forecasts. Identifying and resolving budget issues, and providing program-level financial health summaries are also part of the role. Other duties as assigned.

Requirements

  • Bachelor’s degree in a related discipline required; a combination of relevant education and applicable job experience may be considered.
  • Minimum of 10 years of progressive experience in clinical project management within a CRO, biotechnology, or pharmaceutical organization, including people leadership responsibilities
  • 7 years of supervisory experience.
  • Strong understanding of drug development, clinical operations, and clinical financial management.
  • Demonstrated leadership capability with experience mentoring and overseeing project management staff.
  • Excellent organizational, time management, and communication skills, with the ability to manage multiple priorities in a matrix environment.

Nice To Haves

  • Biology and chemical laboratory environment experience needed.

Responsibilities

  • Oversee timeline, budget and accruals for the clinical studies and clinical programs within the Clinical Operations group.
  • Develop, maintain, and manage high-quality consistent study processes and templates with cross-functional Clinical Operations peers to drive consistent and reliable clinical study outcomes.
  • In collaboration with the Project and Portfolio Management, provide clinical program timeline and budget estimates to support annual budgets and long-range planning (LRP).
  • Oversee and mentor team of Clinical Project Managers as needed.
  • Develop and oversee policies and procedures aimed to streamline Clinical Project Management process.
  • In collaboration with Clinical Trial Operations and Project and Portfolio Management, provide input on annual planning activities to meet corporate study and program objectives.
  • Subject Matter Expert (SME) for study and program clinical timelines and budgets.
  • Oversee routine status reporting including study timeline and budget dashboards and management updates.
  • Ensure teams are providing monthly milestone and timeline updates to Project and Portfolio Management for entry into corporate project management system.
  • In collaboration with Project and Portfolio Management, develop program scenario plans and support life cycle management activities as needed, support creation and incorporation of resource demand algorithms into project management software.
  • Oversee and streamline monthly accrual process in partnership with finance.
  • Facilitate and oversee cost accruals by study managers to ensure accuracy.
  • Meet with finance periodically to review accrued costs against forecasts and troubleshoot variances, and to oversee overall spend for studies & programs.
  • Identify potential budget issues and recommend and implement solutions or corrective actions as needed.
  • Provide program-level timeline and financial health summaries for management periodically
  • Other duties as assigned.

Benefits

  • discretionary annual target bonus
  • stock options
  • ESPP
  • 401k match
  • medical insurance
  • dental insurance
  • vision insurance
  • basic life insurance
  • 20 days of PTO
  • 10 paid holidays
  • winter company shutdown
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