For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Job Overview

As the Associate Director, Project Management, you will be assigned projects of increasing complexity. You will manage the full Project Management lifecycle for assigned projects and act as a functional area expert. Where applicable, you will lead and/or support development and implementation of Project Lifecycle Plans. You will develop and manage project plans and manage project timelines, communications, meetings, and other interactions to ensure project deliverables are met on-time, and to the quality expected, working with no supervision. You will represent the Project Team to various partners and stakeholders. You will typically manage multiple projects simultaneously. You will also contribute to short- and long-range RPM strategies, plans and infrastructure development. You will also lead RPM process improvement activities and lead complex Regulatory initiatives and/or complex Development initiatives. This will be an onsite role and can be located in Foster City, CA or Parsippany, NJ.

Essential Duties and Job Functions:

• Directs moderately complex department/cross-functional specific programs and/or initiatives.
• Directs moderately complex project/initiative communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status.
• Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Regulatory Project Team.
• Provides Regulatory Project Management support for programs/projects/initiatives; attends sub-team meetings; organizes ad hoc working groups as needed.
• Provides leadership to the team and functional areas to anticipate and identify complex project issues which pose a challenge to achieving strategic goals; proposes and implements plans to resolve such issues and execute corrective actions.
• Identifies and manages critical path activities and resources.
• Manages 3 – 6 Regulatory Projects, included but not limited to NDAs, MAAs, BLAs, sNDAs/T2Vs, RTQs, submissions across projects/programs (platform).
• In relation to Regulatory submissions, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources.
• Works in partnership with Project Sponsor/Regulatory Lead(s) and stakeholders to ensure timely, efficient and effective meetings and progress on activities between meetings.
• Works in partnership with Project Sponsor/Regulatory Lead(s) to develop, gain approval and execute on strategy.
• Chairs project meetings and coordinates moderately complex team operations and communications.
• Will initiate or contribute to local and global process improvements across therapeutic areas which have a significant impact on the business and work collaboratively with other functional areas and Regulatory Affairs’ functions at other global sites.
• Organizes and/or leads preparation of high-quality documents for review by internal committees and external stakeholders. May author documents and/or procedures for leadership teams.
• Recognized as a functional area expert for specific project and/or programs.
• Has increased development of strategic and enterprise mindset.
• May represent Gilead at external professional meetings or discussions with industry trade groups.
• May develop and implement continuous improvement and optimization initiatives across the department.
• Ensures project work complies with established practices, policies and processes and any regulatory or other requirements.
• Works with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.

Minimum Education & Experience:

• BA/ BS with 10+ relevant project management or scientific experience in the biopharma industry, or 8+ years’ relevant experience with MA/MS/MBA, or 2+ years’ relevant experience with PharmD/PhD, or 0+ years’ experience with MD.
• A scientific background may be required.
• Experience typically includes 5+ years leading cross-functional project management activities within the biopharma industry; building, managing and articulating comprehensive, complex, cross-functional plans.
• Proven effectiveness managing project teams in life sciences, including effectiveness in preparing compelling RFX documentation for senior leadership, determining the appropriate scope of projects, helping project teams develop creative alternative scenarios, and acting effectively as a thought partner to others.
• Proven track record of successfully managing multiple projects simultaneously.
• Line management (direct reports) experience is a plus.
• PMP (Project Management Professional) or other PM certification or equivalent is a plus.

Knowledge & Other Requirements:

• Some management/ mentorship experience preferred.
• PMP or PRINCE2 desired.
• Recognized as a functional area expert for specific products, programs, projects and/or initiatives.
• Ideally have a modest knowledge of regulatory requirements specific to key regions such as the US and EU, and have a general awareness of current global and regional trends in Regulatory Affairs.
• Strong negotiation and conflict resolution skills.
• Has complete knowledge of full cycle project management, from project start-up to close-out, and has shown ability to effectively apply this knowledge to achieve targeted project outcomes.
• 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.
• Has advanced knowledge of functional or therapeutic area, as evidenced by independence in designing, implementing and managing project team plans, deliverables and resource management.
• Demonstrates expertise in developing and managing project scope, deliverables, risks and resource requirements.
• Knowledge of Agile Methodologies and their application in the R&D biopharma environment.
• High degree of organizational awareness and knowledge of change management with the ability to help teams anticipate, plan and adapt to an evolving environment.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Ability to understand and communicate scientific and/or business elements in a clear and concise manner.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly-matrixed environment.
• Demonstrated ability to independently take on and execute multiple complex tasks.
• Ability to take accountability and empower individuals and teams to make effective decisions which are aligned with the company’s vision, values and goals.
• Must be quality driven individual with strong attention to detail and accuracy.
• Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration.
• Advanced knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.
• When needed, ability to travel.

Gilead Core Values:

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences has a strong commitment to diversity and inclusion. 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.

We are an equal opportunity employer. Apply online today at www.gilead.com/careers.

The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.