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
JOB DESCRIPTION:
You will support or lead multiple components of clinical trial programs in Inflammation/Fibrosis clinical development, including primary biliary cholangitis (PBC) or other liver disease indications with potential for opportunities across the Inflammation therapeutic area at Gilead.
Responsibilities may include clinical study design; protocol preparation; support for successful study start-up, maintenance, or close out; conduct or oversight of data cleaning to ensure high quality analyses; conduct or oversight of medical monitoring; contributions to data analysis plans and clinical study report drafting; providing clinical development input into regulatory documents or health authority interactions; leading efforts on publications and scientific communication of study results; thought leader engagement and representing Gilead among external stakeholders; providing clinical and scientific leadership on cross-functional teams.
Stage of studies to which you may be assigned include Phase 2, Phase 3, and Phase 4, with potential for earlier phase work as well. This is an opportunity for exposure and leadership across a range of clinical development activities. The ideal candidate will have strong scientific acumen, interest in learning across new indications, passion for collaboration and teamwork in a fast-paced environment, and excellent communication skills.
EXAMPLE RESPONSIBILITIES:
Provide or oversee medical monitoring for clinical trials
Provide input into, or lead, clinical trial protocol strategy, design, and content
Support successful study start-up, maintenance, and/or closeout
Present at clinical study investigator meetings and represent Gilead in interactions with investigators in other settings
Serve as clinical reviewer of data listings for data cleaning, ensuring accurate and complete data to support high-quality analyses
Collaboration with Biostats on analysis planning and generation of study results
Provide input into, or lead, clinical study report content and responses to health authority inquiries
Provide input into the Target Product Profile and support, or lead, creation of the Clinical Development Plan for assigned molecules /products
Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
Lead the clinical development component(s) in the preparation/review of investigator brochures or other regulatory documents
Lead scientific communication of data through scientific conference abstract submissions and through manuscripts
Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
Basic Qualifications
PhD/ Pharm D and 8 years’ clinical, scientific and/or drug development experience in the biopharma…