Title: Project Manager II (Clinical Pharmacology)
Location: Foster City, CA 94404 (hybrid)
Duration: Contract - 1 year +
MUST BE LOCAL TO THE BAY AREA AND BE AUTHORIZED TO WORK IN THE US WITHOUT SPONSORSHIP ON A W2 HOURLY. *HYBRID ROLE
Must have previous Pharmaceutical or Biotech experience.
Job Details
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
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