Sr Director, Clinical Research (MD)
Sr Director, Clinical Research (MD)
United States - California - San Diego
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
The Sr Director, Clinical Research, position will lead a team dedicated to Pediatric infectious disease clinical research, including the design, conduct, and evaluate of Phase 1, 2, and 3 clinical trials. This role will be involved in HIV treatment, prevention, and/or cure research, viral hepatitis, and other viral infections.
- Interfaces with staff to share scientific and clinical information and consistent practices.
- Leads/supports protocol review discussions concerning scientific and procedural aspects of study design.
- Serves as resource for junior staff.
- Oversees the scientific aspects of clinical studies throughout duration of study.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
- Supervises or assists other CRS staff with preparation of above. Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
- Helps ensure consistency across protocols.
- Presents scientific information if needed.
- Addresses questions regarding scientific and related procedural issues from Investigators.
- Coordinates and implements ongoing data for internal analysis and review.
- Coordinates/supports the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs as well as fulfillment of pediatric regulatory requirements
- Determines the functions most critical to company success and supports priorities within functional area.
- Anticipates fairly complex obstacles and client difficulties and implements solutions that meet goals.
- Creates effective teams with a clear sense of direction.
- May lead multiple specific components of departmental strategic initiatives.
Knowledge, Experience & Skills:
- Typically requires a higher degree MD, with 5+ years in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution
- Experience in pediatrics will be highly desirable but not required
- Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
- Examines functional issues from a broader organization perspective.
- Knowledge of clinical trial design to develop specific study concept sheets and protocols is required.
- Familiarity with virology and HIV medicine preferred
- Familiarity with Pediatric infectious diseases and regulatory requirement in pediatric drug development
- Clinical research experience preferred
- Pharmaceutical/Biotech industry experience in clinical development preferred
- Successful leadership and management experience
- Excellent organizational and communication skills are critical
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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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 email@example.com 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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