Senior Manager, Development Project Management, Clinical Pharmacology

Senior Manager, Development Project Management, Clinical Pharmacology
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Job Summary

Acts as the project manager for assigned projects of moderate complexity.

Develops and manages project plans, manages project timelines, communications, meetings, and other interactions to ensure project deliverables are met on-time, to the quality expected and within-budget.

Typically manages multiple projects simultaneously and expected to play a key role in ensuring cross-project synergies are realized.

Specific responsibilities

• Requires managing building Pop PK dataset and process flow, document drafting, ClinPharm timeline in NDA/BLA
• Leads coordination of document drafting with Medical Writing, Regulatory Project Management and the ClinPharm team and multiple stakeholders and contributors
• Manages timelines based on submission plans and internal review process
• Manages deliverables supporting submissions including Pop PK Exposure Data, Pop PK Report, Summary modules, Part 11 Files used to derive Pop PK data, etc.

Essential duties and job functions

• Leads moderately complex assignments that enable multiple functions and teams to achieve their project objectives within targeted timelines and allocated resources.
• Advises other functions on how to best achieve their project goals and objectives.
• Interacts with other functions across Development and Research (key contacts include ClinPharm Rep, Bioanalysis Rep, ClinPharm Management, Clinical Operations, Clinical Data Science and Regulatory Affairs)
• May manage external vendors involved in assigned projects.
• Collaborates and partners with others across Development to ensure assigned projects are completed on-time, within-budget and to the quality expected.

Key Accountabilities/Core Job Responsibilities

• Manages task assignments and output quality of others supporting their projects.
• May have one or more direct reports.
• Provides matrix management to project teams supported. Typically manages multiple teams simultaneously.
• Independently creates and manages project budgets and resource plans for assigned projects, seeking advice as needed.
• Responsible for identifying cross-project synergies to leverage efficiencies and ensure consistencies where appropriate.

• Leads moderately complex projects that enable Development initiatives to proceed. Errors made at this level may cause delays to achieving targeted project outcomes.

• Contributes to best practices and improvements.

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

Education and Experience

8+ years relevant experience with BA/BS

6+ 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 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 and has shown ability to apply these to improve project efficiencies and effectiveness.
• Has significant industry knowledge, including knowledge of drug development, and is able to 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.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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