Sr Director, Clinical Research

Sr Director, Clinical Research
Ireland - Dublin

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 MD, Clinical Research, position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide scientific expertise on pediatric viral infectious diseases.

Essential Functions:

• 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 CR 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, PIPs/PSPs, safety reports, Investigator Brochures, and NDAs.
• Determines the functions most critical to company success and supports priorities within functional area.
• Anticipates fairly complex obstacles and implements solutions that meet goals.
• Creates effective teams with a clear sense of direction.
• May lead two or more specific components of departmental strategic initiatives.

Knowledge, Experience & Skills:

Essential:

• Typically requires a higher degree MD, with significant years in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution
• Experience in pediatric medicine and/or pediatric drug development 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.

Desirable Skills:

• Familiarity with virology and HIV medicine preferred
• Clinical or translational research experience preferred
• Pharmaceutical/Biotech industry experience in clinical development preferred
• Successful leadership and management experience
• Excellent organizational and communication skills are critical

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Ireland---Dublin/Sr-Director--Clinical-Research_R0016438-2





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