Sr. Director, Clinical Development (MD) Oncology
Sr. Director, Clinical Development (MD) Oncology
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.
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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
Sr. Director, Clinical Development (MD) - Oncology
This position will play a supportive role in Hematology/Oncology clinical development, including programs in immuno-oncology and targeted therapies.
Working in collaboration with the Clinical Research lead, the position is responsible for various aspects of ongoing clinical trial program-related activities within the oncology 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, data analysis/reporting and support of NDA/MAA filings.
Essential Duties and Job Functions:
o Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
o Participates in protocol review discussions concerning scientific and procedural aspects of study design.
o Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
o With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
o With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
o With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
o Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
o Supports priorities within functional area.
o Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
o May be asked to coordinate teams and provide direction.
o May lead two or more specific components of departmental strategic initiatives.
o Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
o 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.
o May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Knowledge, Experience and Skills:
o Typically requires a higher degree such as PharmD or PhD in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution and 5 years of clinical research experience.
o 9+ years of relevant scientific and/or drug development experience with a BS degree in Biological Sciences, health care, or a related field.
o 7+ years of relevant scientific and/or drug development experience with a. MS.
o Demonstrated ability to be a fast learner.
o Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
o Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
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 virology, oncology and inflammation.
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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.
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