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Director Clinical Development HBV Cure

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Jan 25, 2022

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Job Details

Director Clinical Development HBV Cure
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


You will typically lead multiple components of clinical trial programs in HBV cure clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable or various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.

This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for HBV cure. The Director, Clinical Development position will play a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide, provide expertise in clinical medicine as a medical monitor, and contribute to cross-functional initiatives.

Essential Duties and Job Functions:
  • Responsible for all scientific aspects of conceptualizing and planning trials.
  • Provides ongoing medical monitoring 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 data for internal analysis and review.
  • Responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
  • 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.
  • Work with regulatory team in the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
  • Serves as a scientific and clinical resource within Gilead Clinical Research
  • Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Biomarkers, Global Drug Safety, Regulatory, and Project Management staff.
  • Assists in the clinical evaluation of business development opportunities.


REQUIREMENTS:

Minimum Education & Experience
  • MD or equivalent with 4+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
  • Board certification in is preferred, including familiarity with clinical development.
  • Experience in immunology, hepatology, and/or infectious disease is desirable but not required
  • Experience in the biopharma industry is preferred.
  • Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
  • Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
  • Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations preferred.
  • Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.


Knowledge & Other Requirements
  • Proven analytical abilities as demonstrated through past experience and/or academic research.
  • Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
  • Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
  • Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings.
  • 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 partner, influence and inspire others.
  • Well-developed sense of integrity, strong work ethic, 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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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.


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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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