Senior Clinical Trials Manager, Clinical Operations - Oncology, Virology, Inflammation & Early Development

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: May 3, 2021

Job Description:

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.**For Current Gilead Employees and Contractors:**Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this job.**Job Description****_CLINICAL OPERATIONS:_** _Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gileads products._**Senior Clinical Trials Manager, Clinical Operations (Sr. CTM)****_Openings across all Therapeutic Areas- Oncology, Virology, Inflammation & Early Development. Positions can be located in Foster City CA, Seattle WA, or New Jersey office sites._**_We are seeking a talented, experienced, and highly motivated candidate to join the Clinical Operations team._**Specific Responsibilities and Skills for Position:**+ Ability to write study protocols, study reports, sections for investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision+ In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines+ Communicates with functional peers regarding project status and issues and ensure project team goals are met+ Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction+ Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements+ Anticipates obstacles and client difficulties and implements solutions to achieve project goals+ Experience in developing RFPs and selection and management of CROs/vendors+ May contribute to development of abstracts, presentations and manuscripts+ Functional expertise to initiate, author or contribute to SOP development, implementation and training+ Participates in the recruiting and hiring process for CPA/CTMAs and supports their professional development+ May manage CPA/CTMA/Sr. CTMA+ Coaches members of a work team and ensures adherence to established guidelines+ Ability to examine functional issues from a broader organizational perspective+ Excellent interpersonal skills and demonstrated ability to lead is required+ Independently manages less complex studies+ Travel may be required**Knowledge:**+ Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies+ Working knowledge and experience with Word, PowerPoint and Excel+ Excellent interpersonal skills and demonstrated ability to lead is required+ Excellent verbal, written, interpersonal and presentation skills are required+ Strong communication and influence skills and ability to create a clear sense of direction is necessary**Experience and Skills:**+ At least 7+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline+ At least 5+ years of experience and a Masters' degree or higher; scientific discipline preferred**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 careers@gilead.com for assistance.For more information about equal employment opportunity protections, please view the EEO is the Law (http://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)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:**Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this job.Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Keywords: Gilead Sciences, Inc., San Mateo , Senior Clinical Trials Manager, Clinical Operations - Oncology, Virology, Inflammation & Early Development, Other , San Mateo, California