Director, Clinical Research, HIV

Director, Clinical Research, HIV
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

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Specific Responsibilities:

This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for HIV treatment. This Director, Clinical Research position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials for novel drugs for HIV treatment and provide expertise in clinical HIV medicine as a medical monitor. You will have an opportunity to contribute to developing drugs to treat, prevent, and possibly even cure HIV infection.

• The clinical research physician will play a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide.
• The successful candidate will have oversight for ongoing and planned product trials within the HIV therapeutic area.
• The Clinical Research MD will report to a senior member of the HIV clinical 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 team responsible for all scientific aspects of conceptualizing and planning trials.
• Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
• 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.
• 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 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.
• Will be part of a 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 Drug Safety, Regulatory, and Project Management staff.
• Assists in the clinical evaluation of business development opportunities.

Knowledge, Experience and Skills:

• MD with Board Certification in Internal Medicine/Infectious Diseases preferred
• Successful leadership and management experience
• Excellent organizational and interpersonal skills are critical
• Passion for and experience with HIV medicine preferred

• Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.

• 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 a robust 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.
• Well-developed sense of 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.
• Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20% travel expected).

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually, and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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.\u200b

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

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