Senior Counsel, Clinical/Research
Senior Counsel, Clinical/Research
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 to join our growing team of attorneys. Our Global Therapeutic Area Legal team provides brand and product counseling support to the different business units within Gilead. The Clinical/Research attorney will be responsible for providing legal support in relation to the development of Gilead's drug pipeline. The primary clients for this role include personnel in Clinical Operations and Clinical Research. The Senior Counsel will also be responsible for interacting with, and managing projects with Clinical Research and Clinical Operations that will involve Medical Affairs, Public Affairs, Government Affairs, and Regulatory.
The Clinical/Research attorney will provide 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. This individual is responsible for collaborating with Clinical Research and Clinical Operations 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 Attorney will also conduct, assist and/or provide input into our business conduct policies, training, monitoring, auditing, communications, enforcement, and defense of investigations.
This role also requires working closely with colleagues who support the Gilead products, Global Compliance, Privacy, Regulatory and potentially other groups to ensure the compliant development of our investigational molecules. The Senior Counsel will be expected to collaborate with attorneys in our International Legal, Pricing and Access, Competition Law, Intellectual Property and other legal functions. 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.
This attorney will report to the Global Head of Development in the Commercial Legal Department. 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 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.
- Act 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.
- Collaborate with various cross-functional departments on communications and management of our clinical trials to help ensure alignment and consistency with Gilead's policies and procedures.
- Partner 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.
- Partners 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.
- Collaborates with the Privacy, Clinical Legal, Quality, Drug Safety, and Regulatory Compliance on the compliant execution of our clinical trials.
- 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.
- 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.
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.
For Current Gilead Employees and Contractors:
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