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Associate Director, Clinical Development

L6

gilead sciencesFoster City, CAtoday
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description: Reporting to the Executive Director (IBD), Clinical Research, the Associate Director, Clinical Development in Clinical Research plays an integral role in the scientific planning, execution and reporting of clinical studies for Gilead's development compounds in inflammation area. You will play a critical role in late-stage inflammatory bowel disease (IBD) clinical development. Working in collaboration with the Clinical Lead for emvistegrast, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study protocol preparation, start-up/execution/close out, data analysis/reporting and support of regulatory filings and answering questions. Acquires and uses knowledge of clinical trial design to develop specific study concept sheets and protocols. Participates in protocol review discussions concerning scientific and procedural aspects of study design. Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with guidance and supervision. With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans. With supervision, addresses questions regarding scientific and related procedural issues from Investigators. With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations. Assists in the preparation/review of regulatory documents. Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions. May provide clinical monitoring for one or more clinical studies or components of larger studies. Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs. MS or PharmD or PhD with scientific and/or drug development experience in the biopharma industry, healthcare, consulting.4+ years' relevant scientific and/or drug development experience (For Associate director 6+ years of experience).Relevant experience in immunology/inflammation TA experience is preferred. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Proven analytical abilities as demonstrated through past experience and/or academic research. Understands drug development phases and the nature of associated clinical trials across phases. When needed, ability to travel globally. Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
Summary
Location: United States - California - Foster City
Type: Full time
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Level

LeadL6

Location

Foster City, CA

Occupation

Clinical Research Coordinators

Industry

Research and Development in Biotechnology

Posted

today

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