Job Title: Manager, Development Project Management, Clinical Pharmacology (CLIN Pharm)

Duration: 6 months

Location: Foster City, CA 94404 Onsite Role

Pay Rate: $57.00/hr. on W2

Job Summary

• The Manager, Development Project Management, Clinical Pharmacology (CLIN Pharm) manages assigned projects of simple to moderate complexity. The role involves developing and managing project plans, timelines, communications, and meetings to ensure timely and high-quality project deliverables within budget. The individual will typically manage multiple projects simultaneously and work to ensure cross-project synergies.

Specific Responsibilities

• Oversee CLIN Pharm Sub teams (CPSTs) and Protocol Concept Sheet development.
• Support the CLIN Pharm Submission Working Group (CSWG) by developing, coordinating, and managing timelines for NDA/BLA submissions.
• Manage CLIN Pharm deliverables aligned with submission strategies and the CLIN Pharm Review and Approval process (e.g., PK data, PopPK data, eSub packages).
• Oversee CLIN Pharm portfolio and operations, including developing and maintaining CPPM SharePoint sites, templates, processes, and workflow diagrams.

Essential Duties and Job Functions

• Lead projects to achieve objectives within timelines and resources.
• Advise functions on achieving project goals using past precedence and Clin Pharm PM best practices.
• Collaborate with other functions (Clin Pharm Lead, PMx lead, BioA lead, etc.) to ensure project completion.
• Ensure projects are completed on time, within budget, and to expected quality.

Key Accountabilities/Core Responsibilities

• Manage task assignments and quality of output from team members.
• Provide matrix management to project teams.
• Create and manage project budgets and resource plans.
• Identify cross-project synergies to improve efficiencies.
• Lead projects to enable development initiatives.
• Contribute to the development of CPPM best practices.

Education and Experience

• 5+ years relevant experience with BA/BS
• 3+ years relevant experience with MA/MS/MBA
• 0+ years relevant experience with PhD, PharmD, or equivalent
• Project management experience in life sciences, with proven success in managing project teams.
• Knowledge of full-cycle project management and tools (Smartsheet, Timeline Pro, Visio).
• Experience in drug development and filing with Clin Pharm is a plus.