Senior Director, Clinical Research - Viral Hepatitis (HBV, HCV, HDV)

Location
Foster City, CA, United States
Posted
Jul 06, 2021
Ref
2251805
Required Education
Bachelors Degree
Position Type
Full time
Senior Director, Clinical Research - Viral Hepatitis (HBV, HCV, HDV)
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

Key Responsibilities

The senior director will play a key role in all stages of clinical development for product programs from early stage development through product registrations and key late stage development projects world-wide.
  • Strategic input and oversight for ongoing and planned product trials within the Gilead antiviral portfolio focused on the treatment and potential cure/elimination of viral hepatitis (HBV, HCV, and HDV)
  • Develop and execute Phase 1, 2, and 3 clinical trials and provide scientific expertise on viral hepatitis treatments and disease management. This role may also be involved in our ongoing HBV cure research effort
  • Report to a senior member of the virology leadership team who has direct responsibility for the overall research strategy and clinical and scientific development activities


Essential Duties and Job Functions
  • Will be part of a dynamic team responsible for all scientific aspects of conceptualizing, planning and executing trials
  • Will be part of a cross-functional team responsible for the preparation/review of regulatory documents, IND annual reports and safety reports, investigator brochures, and development plans
  • Provides ongoing medical monitoring and/or serves as study director for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
  • Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
  • Coordinates the collection and analysis of clinical trial data for internal analysis and review, including participation in secondary and translational analyses intended to further our understanding of the biology, epidemiology, clinical features, and underlying treatment concepts for viral hepatitis
  • Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA/MAA/other regulatory submissions
  • Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings
  • Develops manuscripts for publication in peer-reviewed journals
  • Will be part of a cross-functional team responsible for defending the clinical development program before regulatory authorities
  • Serves as a scientific and clinical resource within Gilead Clinical Research
  • Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Public Safety, Regulatory, and Project Management staff
  • Assists in the clinical evaluation of business development opportunities
  • May lead two or more specific components of departmental strategic initiatives


Knowledge, Skills and Experience

We're seeking a strategic, influential leader with the following:
  • MD, DO, PharmD, or equivalent
  • Experience in infectious diseases and/or liver diseases is highly desirable
  • Five (5) + years' experience in clinical research, clinical pharmacology, or medical affairs in a pharmaceutical company, contract research organization, or academic institution with a proven success record in clinical research studies, trial design, execution and oversight
  • Experience in the design of study protocols, consent forms, case report forms, database design, data analysis and the construction of appropriate tables and figures
  • Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices; direct experience in the study recruitment is highly desirable
  • Direct experience in the strategic, and tactical implementation of drug development
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans
  • Strong leadership skills with an ability to set vision, lead change, and mentor others
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster sharing of ideas and creative problem solving
  • Excellent scientific written and oral communication skills
  • Ability to partner, influence and inspire others
  • Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
  • Integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality


The Gilead Difference

Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it's not just what we do that gives us an edge, it's how we do it. We expect everyone at Gilead to lead by example, guided by our core values:
  • Integrity - Doing What's Right
  • Inclusion - Encouraging Diversity
  • Teamwork - Working Together
  • Accountability - Taking Personal Responsibility
  • Excellence - Being Your Best
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:
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