Senior Counsel, Global Legal Head of Development - Medical Affairs

Location
Foster City, CA, United States
Posted
Jan 05, 2021
Ref
2112757
Required Education
Bachelors Degree
Position Type
Full time
Senior Counsel, Global Legal 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. Gilead’s 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 company’s five core values. That’s 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

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. 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.Senior Counsel II, Global Legal Head of Development-Medical AffairsSpecific ResponsibilitiesThe Global Legal Head of Development-Medical Affairs is responsible for providing business conduct legal support to our Medical Affairs, Clinical Operations, and Clinical Research departments. The individual 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. The candidate 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. This role is part of the team of brand 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 Global Legal Head of Development-Medical Affairs 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 and support educational/scientific activities of our 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 and Medical Affairs programs. This individual would also conduct, assist and/or provide input into our compliance policies, training, monitoring, auditing, communications, enforcement, and defense of investigations.The role reports 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 report in fulfilling his/her role.This role requires a person that can identify, communicate, coordinate, strategize 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 legal guidance and approval to Development and Medical Affairs, 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.
  • Acting as a point-of-contact between Development-Medical Affairs 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.
  • Collaborating 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.
  • Partnering with the Global Therapeutic Area Leads within the Global Therapeutic Area Legal team to ensure alignment and consistency in the advice provided to Development-Medical Affairs.
  • 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.


Qualifications
  • Have a Juris Doctorate from a nationally recognized accredited law school.
  • Be a member in good standing of the State Bar of California, or ability to acquire status of Registered In-House Counsel from the California Bar
  • 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.


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 cross-functional projects, and willingness to take initiative
  • Excellent written and verbal communications skills
  • Excellent analytical and problem-solving skills
  • Detail-oriented and well-organized


OtherThis position requires demonstration of Gilead's core values: Teamwork, Accountability, Inclusion, Excellence and IntegrityThis 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
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