Senior Counsel, Global Head of Development - Medical Affairs
Senior Counsel, Global Head of Development - Medical Affairs
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. 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.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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. Gilead's 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.
Gilead Sciences is looking for a Senior Counsel II to join our growing team of brand attorneys. Our Global Therapeutic Area Legal team provides brand and product counseling support to the different business units within Gilead. This individual will operate as the Global Legal Head of Development and will be responsible for providing business conduct legal support to our Medical Affairs, Clinical Operations, and Clinical Research departments. This attorney will support the full scope of day-to-day Medical Affairs initiatives and activities in addition to supporting activities in relation to the development of Gilead's pipeline and post-clinical/late stage support of Gilead's products. They will also be responsible for collaborating with cross-functional partners, e.g., Public Affairs, Government Affairs, Quality and Regulatory, on initiatives driven by Medical Affairs or Clinical Research and Clinical Operations. This role is a key part of the team of lawyers and will work in a highly matrixed environment with therapeutic area brand lawyers, in addition to Global Compliance, Privacy, Regulatory and other groups to ensure the compliant development of, and ongoing medical/scientific educational support for, Gilead's investigational molecules and marketed products . The attorney will be expected to collaborate closely with attorneys in our International Legal, Pricing and Access, Competition Law, Intellectual Property and other legal functions.
The Senior Counsel II, Development will provide legal and compliance input into global strategies and tactics, drive alignment and consistency across the various therapeutic areas where we develop investigational drugs for commercialization. This individual will also support educational/scientific activities related to the disease states in which we have marketed products, including advising field-based personnel such as Medical Science Liaisons. Broadly speaking, the role is responsible for collaborating with Development management to ensure compliant interactions with healthcare professionals, patients, charitable organizations and third parties retained by our business on the running of our Development programs, specifically concentrating in Medical Affairs activities and supervising an attorney related to Clinical activities. This individual would also conduct, assist and/or provide input into our compliance policies, training, monitoring, auditing, communications, enforcement, and defense of investigations.
The successful candidate will report to the Senior Associate General Counsel-Head of the Global Therapeutic Area Support in the Commercial Legal Department. It is anticipated that this individual will have a direct report in fulfilling his/her role. There is a strong preference that this role be based in Foster City, California and however Gilead may consider candidates who are fully remote who are able to travel to Foster City consistently throughout the year.
Roles and Responsibilities:
- Provide legal guidance and approval to Development, and any related sub-teams with respect to clinical trials/development programs, including late stage (e.g., Investigator Sponsored Research, Phase 4 studies) across various therapeutic areas.
- Act as a point-of-contact between Development 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, Investigator Sponsored Research, Collaborative initiatives, and patient engagement activities.
- Collaborate with various cross-functional departments on communications and management of our clinical trials and late stage clinical activities to help ensure alignment and consistency with Gilead's policies and procedures, e.g., Quality, Privacy, Clinical Legal, Drug Safety and Regulatory Compliance.
- Partner with the Global Therapeutic Area Leads within the Global Therapeutic Area Legal team to ensure alignment and consistency in the advice provided to Development.
- Partner 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.
- Ability to operate with a high level of autonomy and agility in an ambiguous and cross-functional environment.
- Experience in 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
- Preferred legal competencies:
- 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.
- Juris Doctorate from a nationally accredited law school.
- Admission to the California state bar, registration as in-house counsel, or ability to gain admission or registration for either within 90 days.
- Minimum of 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.
Gilead Core Values:
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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