Senior Counsel – Development Legal Business Partner

United States - California - Foster CityLegal & ComplianceRegular

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Job Description

Gilead Sciences, Inc. is a global research-based biopharmaceutical company founded in 1987 and headquartered in Foster City, California. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Senior Counsel – Development Legal Business Partner

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.

Core Job Responsibilities Include

Provide regulatory law advice and interpretation for the portfolio of Gilead products, including drug, biologics, and device regulations;
Provide legal support and guidance on product safety and adverse event reporting;
Providing legal support and guidance on data integrity and compliance issues impacting CMC, product quality, GCP, GLP and GMP;
Advising business on a variety of supply chain issues, including drug shortages, product recalls and regional export and import requirements;
Keep up to date and maintain knowledge advising on pertinent regulatory developments relevant to the business in key international markets;
Support and collaborate in a matrixed structure with legal colleagues in Foster City and international affiliates.
Assist in the drafting and review of agreements related to various business needs, including Quality Agreements;
Advise on established products and related considerations, including loss of exclusivity, strategic discontinuation or withdrawal of marketing authorizations, and regulatory data protection;
Proactively identify the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents;
Serve as part of a global matrix of teams and collaborate effectively, including partnering with other members in the Legal and Ethics and Compliance Departments to ensure consistency in guidance and approach across areas of the overall business and help the business operate within legal, regulatory, and ethical requirements;
Establish 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 and mutual respect;
Drive increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders;
Define, direct, and conscientiously manage the work of outside counsel; and
Accountable for providing senior business stakeholders with training and updates, policy support, and learnings to support effective risk management.

Training/Experience Required

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.

Senior Counsel – Development Legal Business Partner

Job Description

Senior Counsel – Development Legal Business Partner

Core Job Responsibilities Include

Provide regulatory law advice and interpretation for the portfolio of Gilead products, including drug, biologics, and device regulations;

Provide legal support and guidance on product safety and adverse event reporting;

Providing legal support and guidance on data integrity and compliance issues impacting CMC, product quality, GCP, GLP and GMP;

Advising business on a variety of supply chain issues, including drug shortages, product recalls and regional export and import requirements;

Keep up to date and maintain knowledge advising on pertinent regulatory developments relevant to the business in key international markets;

Support and collaborate in a matrixed structure with legal colleagues in Foster City and international affiliates.

Assist in the drafting and review of agreements related to various business needs, including Quality Agreements;

Advise on established products and related considerations, including loss of exclusivity, strategic discontinuation or withdrawal of marketing authorizations, and regulatory data protection;

Proactively identify the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents;

Establish 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 and mutual respect;

Drive increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders;

Define, direct, and conscientiously manage the work of outside counsel; and

Accountable for providing senior business stakeholders with training and updates, policy support, and learnings to support effective risk management.

Training/Experience Required

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

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.