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
POSITION OVERVIEW:
Regulatory Affairs (RA) Business Operations believe talented people deserve a great place to work and excellence in our day-to-day operations enables talented people to do their best work! Our Mission and Purpose is to reduce complexity, improve performance and to differentiate value. In doing this we unleash and enable our people to be purposeful and impactful!
Reporting into the Head of RA Business Operations, RA Performance Excellence, you will act as the RA Therapeutic Area (TA) Business Manager and will be accountable for continuously improving operational efficiency, efficacy, and focus of the RA Therapeutic Area sub-functional Leadership Teams (LT). You will partner with sub-functional leadership to translate the organization’s vision into an actionable annual operating plan and establish and manage the sub-functional leadership team’s operational rhythm. You will act as the primary service partner to sub-functional SMEs, translating tools and processes from the Business Operations’ Centers of Excellence into practical, usable solutions tailored for the TA's ways of working. You will manage the inventory of strategic projects (for the subfunction) and priorities, ensure resources are aligned to the highest-value work, and provide leadership with a clear view of progress against strategic goals. You will lead relevant communication efforts for the TAs and act as a change agent for the roll out of new processes, tools, systems, and technologies.
You will support the RA Performance Excellence function to identify, lead, and implement ad hoc or special projects that continuously improve or otherwise advance the RA Performance Excellence capabilities.
RESPONSIBILITIES:
Act as a bridge to ensure alignment with organizational goals, Hub ways of working, and sub-functional execution. Communicates the sub-function’s strategic needs across the Hub to influence capability development and ensures the sub-functions benefit from Hub-led initiatives, encompassing but not limited to:
Vision and Strategy Development
Initiative Portfolio Management
Vendor Management
Strategic Workforce Planning and Resource Management
Change, Communications and Engagement
Performance Management
Regulatory Inspection and Standards Excellence (RISE) Management
Business Process Excellence
TA Leadership Team Operations and Evolution
Build and support a strong liaison community. This includes facilitating the sub-functional leadership team meetings and cross-functional leadership forums.
Establish meeting cadence and manage agendas so the TA LTs can make timely, well-informed decisions, allocate resources to the highest value uses, and have effective line of sight into the value delivered by the organization.
Design and facilitate effective meetings by selecting relevant topics, balancing content review with discussion, and moderating dialogue.
Drive, monitor and improve the overall effectiveness of the TA LTs by managing the team process and introducing solutions to build team effectiveness as necessary.
Track and monitor LT decisions and actions; hold LT members accountable to decisions and actions.
Collaborate with your peers in other functions to share best practices, align, and ensure consistency as appropriate.
Establish goals and KPIs for the supported sub-functions.
Identify and mitigate risks for business areas within the supported sub-functions.
Responsibilities Specific to Liaisons
Represent liaisons on key committees e.g., Functional Area Initiative Review (FAIR).
Serve as liaison point of contact for process improvement and document management. Assign or lead liaison input to update and develop new process documents ensuring that processes are clear and appropriately reflect the work within the liaison scope.
Understands and supports the tactical elements of resource management and vendor engagement, ensuring alignment with budget and priorities.
Contribute to the talent pipeline refinement for liaisons.
Serve as liaison point of contact and coordinator for inspection responses and any subsequent CAPAs [interim].
Support the ongoing evolution and operational management of the Business Management Capability
Establish mechanisms for continuous feedback and improvement to LT and Business Management processes.
Adapt and refine approaches to respond to evolving business needs, external conditions, and stakeholder expectations.
Basic Qualifications:
Bachelor's Degree and Twelve Years’ Experience
OR
Masters' Degree and Ten Years’ Experience
OR
PhD and Eight Years’ Experience
Preferred Qualifications:
MA / MS / MBA or other advanced degree with 10+ years’ relevant experience
BA / BS with 12+ years’ relevant experience
Significant regulatory, quality, compliance, or related experience in the biopharma industry.
Significant experience in navigating a matrix organization. Experience with process improvements and organization shifts in culture.
Demonstrated abilities to effectively delegate, manage, and influence others, as evidenced through either past people management or matrix management responsibilities.
Life Sciences management consulting experience is a plus
Strong leadership presence with demonstrated ability to lead without authority and influence people, projects and/or initiatives.
Strong ability to adapt to evolving business requirements, assimilating and prioritizing changes into ongoing strategies and plans.
Proactive in gathering, interpreting, and evaluating data to drive decision-making and actionable recommendations.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
Comprehensive understanding of the research and drug development life cycle, including roles, systems, and processes.
Familiarity with global regulatory frameworks and submission processes (e.g., NDAs, MAAs).
Proficiency in Microsoft Office tools. Knowledge of Smartsheet tools (including Resource Manager, Control Center) is highly preferred.
Strong negotiation and conflict resolution skills.
Strong coaching capabilities to mentor/develop staff.
When needed, ability to travel.
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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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For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.