Director/Sr Director, Clinical Research (MD) HIV Prevention
Director/Sr Director, Clinical Research (MD) HIV Prevention
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
This is an opportunity to work in a dynamic role to support the clinical development of novel and innovative drugs for HIV infection. This Senior Director, Clinical Research position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical HIV medicine. This role will primarily be involved in developing long-acting drugs for HIV prevention and may also support programs for HIV treatment and for HIV cure research. Working in collaboration with the HIV Prevention Program Lead, this position is responsible for various aspects of ongoing clinical trial program-related activities within the HIV therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of NDA/MAA/ROW filings.
Essential Duties and Job Functions:
- Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.
- Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
- Provides ongoing clinical medical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, 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 clinical study investigator meetings, internal, and external meetings
- Leads two or more specific components of cross-functional strategic initiatives.
Knowledge, Experience and Skills:
- At least 6 years of relevant experience in clinical research in clinical drug development, in pharma, biotech, or academic clinical trials with an MD, PharmD, or PhD in relevant field.
- 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.
- Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
- 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.
- Excellent scientific written and oral communication and interpersonal skills are required.
- Must be capable of working with attention to detail in a time sensitive environment.
- Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is required.
- Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job related programs such as Spotfire and RDMS
- Ability to partner, influence and inspire others.
- Ability to travel domestically and internationally once COVID19 restrictions are lifted to company, scientific, regulatory, investigator, and other meetings (~20% travel expected).
- Familiarity with clinical virology and in particular HIV prevention and treatment preferred
- Direct experience in the strategic, and tactical implementation of drug development
- Experienced with engaging internal and external expert physicians, scientists, and other key stakeholders, including community and civil society leaders, in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
- Successful leadership and management experience
- Experience in business development and assessment of opportunities is desired
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.
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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 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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