Job Description
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 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. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status.
POSITION OVERVIEW:
As a Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise Lead and cross functional stakeholders in compliance with the appropriate regulations. You will act as the Global or Regional Regulatory Lead on complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects in early Oncology to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. Though the role is primarily focused on early oncology assets, you may act as the Global Regulatory Lead for early-stage, late-stage, or other programs depending on business needs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams including Project Strategy Teams. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will provide operational and technical regulatory assistance through all stages of clinical development through global registration, as needed. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues and regional leads.
Location: Foster City, CA or Parsippany, NJ or Cambridge or Stockley Park
FUNCTION: Global Therapeutic Area (TA) Regulatory Liaisons
RESPONSIBILITIES:
- Accountable for the successful oversight and completion of a broad spectrum of regulatory activities and deliverables for products, compounds, indications and/or other projects in the oncology therapeutic area.
- As needed, represents Gilead in negotiations with regulatory authorities. Oversees contacts for local regulatory authorities.
- Works on extremely complex problems and provides solutions that have significant impact.
- Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
- Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and Project Strategy Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
- Advises other functions on short- and long-range regulatory strategies, plans, resources and tactics as the global regulatory representative in cross functional meetings such as the program strategy team and global development team.
- May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
- Defines, oversees, and communicates the regulatory strategy for assigned products or projects.
- Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
- Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, original New Drug Application (NDA), supplemental NDAs, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).
- Oversees the authoring and approval of regulatory documents, including meeting requests, Module 1 documents for original IND/NDA, etc.
- May oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
- Critically reviews documents for submission to regulatory authorities.
- May have one or more direct reports.
- Provides matrix management and leadership to project teams.
- Provides accurate and thorough input and recommendations into resource plans required to complete team deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
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.
U.S. Education & Experience
- PharmD/PhD with 8+ years' relevant experience.
- MA/MS/MBA with 10+ years' relevant experience.
- BA/BS with 12+ years' relevant experience.
- Extensive regulatory, quality, compliance or related experience in the biopharma industry.
- Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
- Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
- Experience and proven effectiveness working and negotiating with regulatory authorities.
- Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
- Line management (direct reports) experience is strongly preferred.
- Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
- Proven track record of successfully managing large scale, complex, time-sensitive projects.
- Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
Rest of World Education & Experience
BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience in in vitro diagnostic development strongly preferred
Knowledge & Other Requirements
- Expert knowledge of the drug development process, global and regional regulatory requirements for medicinal products.
- Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.
- Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
- In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
- Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- 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.
- Strong negotiation and conflict resolution skills.
- Strong coaching capabilities to mentor/develop staff.
- When needed, ability to travel.
The salary range for this position is: $210,375.00 - $272,250.00. 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' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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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 apply via the Internal Career Opportunities portal in Workday.
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.