Sr Director, Clinical Research-Gastroenterology(MD)
Sr Director, Clinical Research-Gastroenterology(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. 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
Specific Responsibilities for Position:
- You will oversee scientific and medical studies involving internal assets targeting inflammatory bowel disease.
- You will provide input and direction on strategic development of internal assets from the drug discovery stage through product registrations worldwide.
- You will report to a more senior member of the inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.
Duties and Job Functions:
- Conceptualizing, planning and executing clinical trials.
- Preparation and review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
- Medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Manage the preparation and/or review of data listings, summary tables, study results, study reports, and clinical modules for filings.
- Prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
- Develop manuscripts for publication in peer-reviewed journals.
- Provide scientific and clinical guidance to Biology, Toxicology, Clinical Operations, Biometrics, Global Drug Safety, Regulatory, and Project Management functional areas
- Assist in the clinical evaluation of business development opportunities.
Knowledge, Experience and Skills:
- MD or equivalent. Gastroenterology fellowship or experience in gastroenterology preferred.
- Three (3) + years experience in drug development. Experience in drug development for IBD or other inflammatory diseases preferred.
- Experience in the oversight and design of clinical research studies with understanding of Good Clinical Practice.
- Ability to understand and communicate scientific concepts related to drug pharmacology, pharmacokinetics and toxicology.
- Experience with developing relationships and collaborations with external experts in discussions related to study design, study conduct, and interpretation of clinical results.
- 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.
- 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 skills.
- Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (10% travel expected).
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 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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