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Manager, Development Project Management, Clinical Pharmacology (ClinPharm)

Foster City, CA 94404

Posted: 01/22/2025 Employment Type: Contract Job Category: Project Management Job Number: 616778 Is job remote?: Hybrid Country: United States

Job Description


Target PR Range: 47-57/hr
*Depending on experience

Job Summary
  • Acts as the project manager for assigned projects of simple to moderate complexity.
  • With little guidance from the Clin Pharm Project Management leader, develops and manages project plans, timelines, communications, meetings, and other interactions to ensure project deliverables are met on time, to the expected quality, and within budget.
  • Typically manages multiple projects simultaneously and is expected to play a key role in ensuring cross-project synergies are realized.

Specific responsibilities
  • Oversee ClinPharm Subteams (CPSTs) and Protocol Concept Sheet development at the asset level, ensuring the execution of Clinical Pharmacology strategies to support program lifecycle management.
  • May support the CliniPharm Submission Working Group (CSWG) by developing, coordinating and managing timelines for NDA/BLA submissions, leading cross-functional matrix teams comprising Medical Writing, Data Management, Regulatory Project Management, ClinOps, BioStats, and Clin Pharm team members.
  • Manage submission-level ClinPharm deliverables and milestones aligned with submission strategies and the ClinPharm Review and Approval process. Key deliverables include QC/QA-ed PK data, PopPK data, E-R data, Pop PK reports, E-R reports, eSub packages, m2.7.1, m2.7.2, and other regulatory components.
  • Oversee the ClinPharm portfolio and operations, including developing and maintaining CPPM SharePoint sites, templates, processes, and workflow diagrams.

Essential duties and job functions
  • Leads simple to moderately complex assignments that enable multiple functions and teams to achieve their project objectives within targeted timelines and allocated resources.
  • Leverages past precedence and Clin Pharm PM best practices to advise other functions on how to best achieve their project goals and objectives.
  • Interacts and collaborates with other functions; key stakeholders include Clin Pharm Lead, PMx lead, BioA lead, CPPM, Clin Ops, RPM, CDM, Medical Writing, and Regulatory Affairs)
  • Collaborates and partners with others across Development to ensure assigned projects are completed on time, within budget, and to the expected quality.

Key Accountabilities/Core Job Responsibilities
  • Manages task assignments and output quality of others supporting their projects.
  • Provides matrix management to project teams supported. Typically manages multiple teams simultaneously.
  • With support from the TA Project Management lead, creates and manages project budgets and resource plans for assigned projects.
  • Support identifying cross-project synergies to leverage efficiencies and ensure consistencies where appropriate.
  • Leads simple to moderately complex projects that enable Development initiatives to proceed. Errors made at this level may cause delays to achieving targeted project outcomes.
  • Contributes to CPPM best practices and improvements.
  • Identifies cross-project synergies that accelerate our progress and maximize efficiencies.

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
  • Where applicable, multiple years project management experience in life sciences, including multiple years experience co-managing project teams.
  • Where applicable, proven effectiveness in managing project teams in life sciences.
  • Has complete knowledge of full-cycle project management, from project start-up to close-out.
  • Has advanced knowledge of project management best practices and tools (SmartSheet, Timeline Pro and Visio) and has shown the ability to apply these to improve project efficiencies and effectiveness.
  • Has significant industry knowledge, including knowledge of drug development, and can flex own knowledge to work on molecule and/or non-molecule projects.
  • Independently solves problems incurred and seeks advice when needed. Ensures solutions are consistent with organizational objectives.
  • Coaches less experienced team members in resolving problems. Experience with filing and Clin Pharm will be a plus

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Foster City, CA

Discover your next career opportunity in the vibrant job market of Foster City, California! Nestled in the heart of the San Francisco Bay Area, Foster City presents a perfect blend of scenic beauty and bustling industry. With top-notch companies, such as Visa and Gilead Sciences, calling this region home, job seekers can find a plethora of growth opportunities in various fields like technology, biotech, and finance. Explore job listings in this charming city known for its picturesque lagoons, beautiful parks like Leo J. Ryan Park, and the iconic Foster City Shell Mound. Indulge in the diverse culinary scene, catch a show at the Hillbarn Theatre, and cheer for the local sports teams like the San Francisco Giants at Oracle Park. Begin your career journey in Foster City today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.