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Senior Counsel, Global Legal Head of Development - Medical Affairs

Employer
Gilead Sciences, Inc.
Location
Foster City
Salary
See job description.
Closing date
Feb 4, 2021

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Other
Organization Type
All Industry, Pharma

 


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. 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

About usGilead 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 a key 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 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 report in fulfilling his/her role. Whilst the preference is for the role to be based in Foster City, CA, consideration will be given to remote candidates.

This position requires a person that can identify, communicate, coordinate, strategize and manage various issues, projects and initiatives simultaneously and across geographies and cultures. The ideal candidate will 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 crossfunctional 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
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

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

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Counsel--Global-Medical-Affairs-Business-Conduct-Attorney_R0015354-1





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