Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Gilead Employees and Contractors:
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Job Description
Senior Counsel, Clinical/Research Business Conduct Attorney
About us
Gilead Sciences, Inc. is a research-based biopharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Being here matters. 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.
Specific Responsibilities
The Clinical/Research Business Conduct attorney is responsible for providing legal support in relation to the development of Gileads pipeline. The primary clients for this role include personnel in Clinical Operations and Clinical Research but will also be responsible for interacting and managing projects with Medical Affairs, Public Affairs, Government Affairs, and Regulatory. This role also requires working closely with colleagues who support the Gilead products, Global Compliance, Privacy, Regulatory and other groups to ensure the compliant development of our investigational molecules. The attorney will be expected to collaborate with attorneys in our International Legal, Pricing and Access, Competition Law, Intellectual Property and other legal functions.
The Clinical/Research Business Conduct attorney provides legal and compliance input into global strategies and tactics, drives alignment and consistency across the various therapeutic areas where we develop investigational drugs for commercialization. Broadly speaking, the role is responsible for collaborating with Clinical to ensure compliant interactions with healthcare professionals, patients, charitable organizations and third parties retained by our business on the running of our clinical programs. The Clinical/Research Business Conduct Attorney would also conduct, assist and/or provide input into our business conduct policies, training, monitoring, auditing, communications, enforcement, and defense of investigations.
The role is based in Foster City, California, although has the option to be remote, and reports to the Senior Associate General Counsel-Head of the Global Therapeutic Area Support in the Commercial Legal Department.
This role requires a person that can identify, communicate, coordinate and manage various issues, projects and initiatives simultaneously and across geographies and cultures. This role also requires a person who can proactively engage stakeholders in advising on legal issues and coming to appropriate resolutions in a timely manner.
Essential Duties and Job Functions
* Provide guidance and approval to Clinical Operations and Clinical Research teams, and any related sub-teams with respect to clinical trials/development programs across various therapeutic areas.
* Acting as a point-of-contact between Clinical Research and Clinical Operations with other Legal teams related to projects and activities, specifically coordinating with such counsels to help ensure alignment and understanding of the global initiatives, e.g., clinical trials and their management.
* Collaborating with various cross-functional departments on communications and management of our clinical trials to help ensure alignment and consistency with Gileads policies and procedures.
* Partnering with the Global Therapeutic Area Leads within the Global Therapeutic Area Legal team to ensure alignment and consistency in the advice provided to Clinical Operations and Research.
* Partnering with the Global Compliance Team to provide insights into Training and Monitoring, as well as, with Risk Assessments/Anti-Bribery-Anti-Corruption, and Value and Access to coordinate our global efforts.
Skills Required
* Operates at a high level of autonomy and who has proven that he or she is able to very competently lead a complex area of responsibility or department that requires significant experience.
* Has proven judgment in working through complex issues, including those with significant strategic risk to the company. Developing ability to apply judgment to areas outside of core competency.
* Leadership and project management in crossfunctional projects, and willingness to take initiative
* Excellent written and verbal communications skills
* Excellent analytical and problem-solving skills
* Detail-oriented and well-organized
Qualifications
* Have a Juris Doctorate from a nationally recognized accredited law school.
* Admission to applicable state bar, registration as in-house counsel, or ability to gain admission or registration for either in applicable state within 90 day
* 8-10 years prior in-house or law firm experience providing legal counsel on the laws and regulations relating to drugs or devices, demonstrating growth and ability to succeed.
* Detailed knowledge of the US Anti-Kickback Statute, False Claims Act, HIPAA, privacy-laws, advertising laws and regulatory guidances, Food, Drug and Cosmetic Act and other government regulation of pharmaceutical products OR similar laws internationally is required. Specifically, familiarity with clinical trial programs and their management is a plus.
* Familiarity with these additional areas is also helpful: Foreign Corrupt Practices Act and other relevant anti-bribery laws, guidance on Patient-Focused Drug Development activities, and legal contract principles.
* Must have demonstrated high EQ and client-service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients.
* Must have demonstrated skills, depth and expertise depending in area(s) of responsibility.
* Have exceptional and demonstrated written and verbal communication skills.
Other
* This position requires demonstration of Gileads core values: Teamwork, Accountability, Inclusion, Excellence and Integrity
* This position requires working within a team extensively and accordingly, the ability to work collaboratively and efficiently with others is critical. You must possess strong interpersonal skills, EQ, professionalism and the ability to work well with a variety of different personalities to be successful in this role.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Foster City, CA
Gilead Sciences, Inc., a research-based biopharmaceutical company, discovers, develops, and commercializes medicines in the areas of unmet medical needs in the United States, Europe, and internationally. The company’s products include Biktarvy, Descovy, Odefsey, Genvoya, Stribild, Complera/Eviplera, Atripla, and Truvada for the treatment of human immunodeficiency virus (HIV) infection in adults; and Vosevi, Vemlidy, Epclusa, Harvoni, and Viread products for treating liver diseases.
It also provides Yescarta, a chimeric antigen receptor T cell therapy for adult patients with relapsed or refractory large B-cell lymphoma; Zydelig, a kinase inhibitor; Letairis, an oral formulation of an endothelin receptor antagonist for pulmonary arterial hypertension; Ranexa, a tablet to treat chronic angina; and AmBisome, an antifungal agent to treat serious invasive fungal infections. In addition, the company offers its products under the name Cayston, Emtriva, Hepsera, Sovaldi, and Tybost. Further, it develops product candidates for the treatment of HIV/AIDS and liver diseases, hematology/oncology, inflammation/respiratory diseases, and others.
The company markets its products through its commercial teams; and in conjunction with third-party distributors and corporate partners. Gilead Sciences, Inc. has collaboration agreements with Bristol-Myers Squibb Company; Janssen Sciences Ireland UC; Japan Tobacco Inc.; Galapagos NV; Scholar Rock Holding Corporation; Tango Therapeutics; National Cancer Institute; Pfizer, Inc.; Sangamo Therapeutics, Inc.; Gadeta B.V.; HiFiBiO Therapeutics; Agenus Inc.; HOOKIPA Pharma Inc.; Goldfinch Bio, Inc.; and insitro Inc. The company was founded in 1987 and is headquartered in Foster City, California.