Senior Manager, Development Project Management - Regulatory

Senior Manager, Development Project Management - Regulatory
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle

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

For Current Gilead Employees and Contractors:

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

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description


You will act as the Project Manager for assigned projects. 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 under minimal and at times no supervision. You will represent the Project Team to various partners and stakeholders. As assigned, you will also develop and lead continuous improvement and optimization initiatives that may have impact across GPM. You will typically manage multiple projects simultaneously. As assigned, you will also lead RPM process improvement activities, lead complex Regulatory initiatives and/or simpler Development initiatives

EXAMPLE RESPONSIBILITIES:

• Leads and manages moderately complex department/cross-functional specific programs and/or initiatives.
  
• Leads and manages 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.
  
• 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.
  
• May manage the work of less experienced colleagues, contractors, vendors and/or third parties.
  
• 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 Sponsor/Regulatory Lead(s) to develop, gain approval and execute on strategy.
  
• Co-chairs project meetings and coordinates moderately complex team operations and communications.
  
• 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.
  
• May manage at least one direct report.
  

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• BA/ BS with 8+ relevant project management or scientific experience in the biopharma industry, or 6+ years' relevant experience with MA/MS/MBA, or 0+ years' experience with PharmD/PhD.
  
• A scientific background may be required.
  
• Experience typically includes 3+ years leading cross-functional project management activities within the biopharma industry; building, managing and articulating comprehensive, complex, cross-functional plans.
  
• Typically required to demonstrate proven effectiveness managing project teams in life sciences, including proven capabilities for effectively and efficiently facilitating project meetings and decision-making.
  
• Typically expected to have a 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.
  
• 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.
  
• Demonstrated ability to lead 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.
  

The salary range for this position is: $160,820.00 - $208,120.00. 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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.






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