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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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Associate Director (MD), Clinical Development
As Associate Director of Clinical Development, you will typically lead one or more components of clinical trial programs in the inflammation and fibrosis therapeutic area, including work on seladelpar for primary biliary cholangitis (PBC). You will be accountable for various aspects of ongoing clinical trial and related activities. These activities include, but are not limited to, study protocol preparation, medical monitoring, investigator communication, contributions to data analysis plans, study reporting, clinical development inputs into regulatory documentation, and contribution to publications and scientific presentations. Scope may include phase 3 and 4 studies with an opportunity to contribute across studies of other phases, as appropriate. The ideal candidate will have a strong scientific acumen; desire to work in fast-paced, matrixed environment; and drive to expand his/her skillset as needed to meet team goals.
EXAMPLE RESPONSIBILITIES:
Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
Provide input into clinical trial protocol design, clinical study reports and health authority inquiries
Provide ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
Manage the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans
Coordinate the collection and assimilation of ongoing data for internal analysis and review
Coordinate and manage the preparation and/or review of data listings, summary tables, study results and scientific presentations
Present scientific information at scientific conferences as well as clinical study investigator meetings
Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Basic Qualifications:
MD or equivalent with clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
Doctorate and 5+ years of relevant experience will be considered
Preferred Qualifications:
Board certification hepatology, gastroenterology preferred, however, other backgrounds including pulmonology, rheumatology, or other medical background with experience performing clinical research studies in chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also considered
Experience in the biopharma industry
Experience working on and with cross-functional project / program teams in clinical research or development
Experience supporting clinical study design, medical monitoring, and regulatory filings
Experience supporting clinical publications and presentations
Other Requirements:
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
Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures
Strong communication and organizational skills, organized and self-motivated
Strong desire to develop new expertise and learn new in new areas as needed to accomplish team goals and advance professional development within the biopharma industry
Ability to travel when needed
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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 ApplicantAccommodations@gilead.com for assistance.
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