Senior Counsel II – Development Legal Business Partner (PDM)

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 fulfill their aspirations. Join Gilead and help create possible, together.
Job Description
 

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. 

We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Gilead is seeking a development and regulatory counsel to join its Global Development & PDM Legal Business Partner team.  The candidate will serve as a primary point of contact for the business, be responsible for advising and collaborating on a range of regulatory and development matters throughout the product lifecycle, liaise with other legal experts, and develop solutions for complex business matters.

The successful candidate will be able to work independently and possess a strong knowledge of U.S. pharmaceutical regulatory laws, rules and regulations, industry practices and standards, and have demonstrated experience in analyzing complex issues and developing innovative solutions to business challenges. The candidate will possess a strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance considerations and risk within areas of responsibility and formulate and communicate compliant and practical solutions that meet business objectives. The candidate will work closely with Regulatory Affairs, Regulatory CMC, Quality, Global Patient Safety, Program Strategy Teams (PSTs), Development Teams, Clinical, and global affiliates.  The candidate will work across Gilead’s Corporate and Legal organization to coordinate and communicate legal input on matters in collaboration with other Gilead Legal Business Partners, the Office of Ethics and Compliance, Government Affairs, and Public Affairs, across geographic and therapeutic areas. 

While this position is posted as remote, candidates who are based Foster City, CA and able to work onsite are strongly preferred.

Core Job Responsibilities Include

• Serving as a Legal Business Partner to global Development functions, including Clinical Development, Clinical Operations, Regulatory Affairs, Regulatory Policy and Intelligence, R&D Quality, Patient Safety, and cross-functional Gilead Asset Teams (GATs);
• Providing legal guidance for the portfolio of Gilead products on GXP requirements, adverse-event reporting, data integrity, clinical data management, inspection and audit readiness, quality investigations, product quality and CMC matters, and regulatory submissions and health-authority interactions; Advising the business on a variety of supply chain issues, including drug shortages, product recalls and regional export and import requirements;
• Keeping up to date and maintain knowledge advising on pertinent regulatory developments relevant to the business in the U.S. and key international markets;

• Assisting in the drafting and review of agreements related to various business needs, including Quality Agreements;
• Advising across the product lifecycle, including development strategy, regulatory pathways, established-product considerations, loss of exclusivity, strategic discontinuation or withdrawal of marketing authorizations, and regulatory data protection
• Providing regulatory and development counsel to the Corporate Legal team for mergers and acquisitions, licenses, collaborations, and other strategic transactions;
• Providing legal interpretation of complex and evolving regulatory requirements and translating them into risk-based compliance programs, governance structures, policies, controls, and operational processes that enable compliant execution of business objectives;

• Proactively identifying the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents;
• Supporting and collaborating with  a global matrix of teams effectively, including partnering with other members in Legal, Ethics and Compliance, Government Affairs, Public Affairs, in Foster City and international affiliates, including the Intercontinental Region (ICR) and Global Patient Solutions (GPS),to ensure consistency in guidance and approach across areas of the overall business and help the business operate within legal, regulatory, and ethical requirements;
• Establishing strong partnership relationships with global Research and Development teams, as well as key cross functional teams engaged in development activities, characterized by a high-level of collaboration, responsiveness, strong understanding of scientific and business objectives, and mutual respect;
• Driving increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders;
• Defining, direct, and conscientiously manage the work of outside counsel; and
• Providing senior business stakeholders with training and updates, policy support, and learnings to support effective risk management.
• U.S. Juris Doctorate (J.D.) degree; active law license in at least one U.S. jurisdiction;
  

• U.S. Juris Doctorate (J.D.) degree; active law license in at least one U.S. jurisdiction, 6+ years of legal experience supporting clients in the pharmaceutical industry, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both;

• Experience advising clients on FDA and regulatory matters, preferably with some device expertise;
• Ability to exercise judgment and independently determine and take appropriate action;
• Ability to translate complex legal requirements into practical recommendations and solutions and clearly communicate requirements and rationale for advice;
• Ability to manage workload priorities in a matrixed environment;
• Experience handling multiple projects in fast-paced environment, with a high degree of client service orientation, and performing successfully in cross-functional teams;
• Able to independently handle complex matters with minimal supervision and an understanding of when to elevate issues to senior management for awareness or decision-making;
• Proven judgment in working through complex issues, including those with significant strategic risk considerations;
• Demonstration of excellent interpersonal, strategic thinking, communication, and organizational skills; and
• Consistent demonstration of Gilead’s core values: Teamwork, Accountability, Inclusion, Excellence and Integrity.

Critical Success Factors

• Judgment: Demonstrates expertise and sound judgment, understands how assigned responsibilities support Gilead’s business objectives, and is able to provide practical, risk-balanced advice based upon a thorough understanding of the scope of an issue, taking full advantage of internal networks and external intelligence. Ability to work in grey areas and solution oriented.
• Collaboration: Works in close collaboration with others to gain a firm understanding of available legal, functional, and business resources; integrates information from a number of sources; capably navigates a matrixed environment; and works well in a team in order to achieve optimal business results.
• Anticipation: Anticipates changes in law, enforcement, and/or business objectives; proactively recognizes challenges; develops contingency plans; and adapts approach as necessary to manage risks effectively and mitigate issues before they arise.
• Influencing Skills: Builds strong relationships with business partners to tactfully influence and gain their support to drive desired outcomes. Represents Gilead externally to trade associations and government agencies.

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. 

The salary range for this position is:

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.

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 [email protected] for assistance.

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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.

Please apply via the Internal Career Opportunities portal in Workday.