Senior Manager, Project Management

Arbeitsbeschreibung

Acts as the Project Manager for assigned projects of moderate complexity. Responsible for developing and managing project plans, submission plans, timelines, cross-functional communications, meetings, actions, risks, and other key activities to ensure deliverables are met on time, within budget, and to the expected quality standards. Typically manages multiple projects and submissions concurrently and plays a key role in leading and leveraging cross-project synergies.

Specific responsibilities:

• Serves as the Clinical Pharmacology Project Manager (CPPM), overseeing cross-functional Clinical Pharmacology Subteams (CPSTs) at the asset level to ensure effective management and execution of Clinical Pharmacology strategies that support program lifecycle management. Responsibilities include managing CPST meetings, tracking risks/decisions/actions, developing a portfolio-level view of timelines, setting team goals, and monitoring performance against those goals.

• Leads the cross-functional Clinical Pharmacology Submission Working Group (CSWG) at the submission level to ensure alignment with global filing strategy and timelines. Responsibilities include developing, coordinating, and driving CSWG timelines for NDA/BLA submissions, overseeing risk and action management, managing meetings, and facilitating effective team communication and information flow.

• Proactively manages and engages with cross-functional matrix teams comprising Clinical Pharmacology, Clinical Development, Biostatistics, Clinical Operations, Global Project Management, Medical Writing, Data Management, Statistical Programming, Regulatory Affairs, and other relevant stakeholders to ensure streamlined communication and information flow between CPST and the Global Development Team (GDT), and between CSWG and the Global Filing Team (GFT) and Study Management Team (SMT).

• Manages specific Clinical Pharmacology deliverables and milestones, including but not limited to: Protocol Concept Sheets for early-phase programs, CSRs, QC/QA-ed PK/ADA/NAb data, PopPK datasets, exposure–response (E-R) datasets, PopPK reports, E-R reports, eSubmission packages, and regulatory components such as Modules 2.7.1, 2.7.2, and ISI, ensuring timely execution and delivery.

• Supports operational excellence by developing and maintaining CPPM SharePoint sites, templates, best practices, job aids, and workflow diagrams. Also responsible for managing Clinical Pharmacology portfolio trackers/dashboards, document review and approval processes, and supporting process improvement initiatives as needed.

Essential duties and job functions

• Drives progress of both product and non-product development programs

• Applies project management standards to enable effective portfolio management

• Leads moderately complex assignments, enabling multiple functions and teams to achieve project objectives within targeted timelines and allocated resources

• Advises cross-functional teams on best practices to achieve project goals and objectives

• Collaborates with key stakeholders across Development and Research, including Clinical Pharmacology Leads, PMx Leads, BioA Leads, Clinical Development, Global Project Management, Biostatistics, Clinical Operations, DMPK, and Regulatory Affairs

• May manage external vendors or collaborators involved in assigned projects

• Partners with colleagues across Global Development to ensure projects are completed on time, within budget, and to the expected quality standards

Key Accountabilities/Core Job Responsibilities

• Manages task assignments and output quality of others supporting their projects

• Provides matrix management to project teams; typically manages multiple teams simultaneously

• Independently creates and manages project plans, timelines, risks, decisions, budgets, and resources for assigned projects, seeking advice as needed

• Identifies cross-project synergies to leverage efficiencies and ensure consistency where appropriate

• Leads moderately complex projects that enable Development initiatives to proceed; errors at this level may cause delays in achieving targeted outcomes

• Identifies cross-project synergies that accelerate progress and maximize efficiencies.

Education and Experience

• 8+ years relevant experience with BA/BS

• 6+ years relevant experience with MA/MS/MBA

• 1+ Years relevant experience with PhD, PharmD, or equivalent

• Multiple years of project management experience in the life sciences, including co-managing cross-functional project teams

• Proven effectiveness in leading project teams within the life sciences domain

• Comprehensive knowledge of full-cycle project management and end-to-end processes

• Advanced proficiency in project management tools such as SmartSheet, Timeline Pro, Planisware, Visio, and OnePager, with demonstrated ability to apply these tools to enhance project efficiency and effectiveness

• Strong understanding of the drug development process, with the ability to apply expertise across both large and small molecule projects

• Independently resolves project-related challenges and seeks guidance when appropriate, ensuring solutions align with organizational objectives

• Coaches and mentors less experienced team members in problem-solving and project execution

• Experience with regulatory filings and Clinical Pharmacology is a plus