Sr Associate Director, Clinical Development HIV MD
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 #CreatingPossibleFor Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job Description
This is an opportunity to work in a dynamic role to support the clinical development of novel and innovative drugs for the treatment of HIV infection. This Clinical Development position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical HIV medicine. This role will be involved in developing compounds across multiple classes for HIV treatment and for HIV cure/remission. You will typically lead multiple components of clinical trial programs in the clinical development of treatments for HIV. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. Activities include, but are not limited to, collaboration with colleagues across functional areas in designing/executing/interpreting clinical trials, clinical study start-up/execution/close out, medical monitoring, data analysis/reporting support of IND/NDA/MAA/other regulatory filings and scientific publication and presentations.RESPONSIBILITIES:
- Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
- Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
- Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
- Coordinates the collection and assimilation of ongoing data for internal analysis and review.
- Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Presents scientific information at scientific conferences as well as clinical study investigator meetings.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Minimum Education & Experience
Knowledge & Other Requirements
- MD or equivalent with 2+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
- Board certification in Internal Medicine/Infectious Diseases is preferred, including familiarity with clinical HIV treatment.
- Experience in the biopharma industry is preferred.
- Experience leading cross-functional project teams in clinical research or development.
- Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations is preferred.
- Proven effectiveness managing clinical project deliverables through matrix management.
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Proven analytical abilities as demonstrated through past experience and/or academic research.
- Understands drug development phases and the nature of associated clinical trials across phases.
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
- Strong communication and organizational skills.
- When needed, ability to travel.
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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 firstname.lastname@example.org
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For Current Gilead Employees and Contractors:
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to apply for this job.