Director, Clinical Development

Director, Clinical Development (Inflammation/Fibrosis) Director, Clinical Development (Inflammation/Fibrosis) United States - California - Foster City Clinical Development & Clinical Operations Regular
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.
As Director of Clinical development in the Inflammation/Fibrosis therapeutic area, you will lead or support multiple components of clinical trial programs, including primary biliary cholangitis (PBC) and/or other indications. You will be expected to provide scientific and clinical leadership or input on activities including study protocol preparation, other study or investigator documentation, medical monitoring, data analysis plans, study reporting, and clinical development input into regulatory documentation, publications, and scientific presentations. The ideal candidate will have a strong scientific acumen; This is a site based position at our Global Headquarters in Foster City, CA.
Lead or support clinical trial protocol design, clinical study report development, and response to health authority inquiries
Serve as medical monitor for clinical trials or oversee medical monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional team
Provide scientific and clinical guidance to cross-functional team members and colleagues to meet clinical development project deliverables and timelines
Lead or support the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products
Lead or support clinical development contributions in the preparation/review of regulatory documents, investigator brochures, and development plans
Lead or support the collection and interpretation of data for internal analysis and review, ensuring high quality data and appropriate analyses performed
Provide scientific and clinical leadership in the preparation, review, and interpretation of clinical trial data
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
We are all different, yet we all use our unique contributions to serve patients. MD or equivalent with 4+ years’ clinical, scientific and/or drug development experience in the biopharma industry, academia, or a related environment
Board certification in hepatology, gastroenterology is preferred; however, other backgrounds including pulmonology, rheumatology, or other internal medicine 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 is preferred, with clinical experience in medical monitoring and familiarity addressing medical concerns
Significant experience working on, with and leading cross-functional project/program teams in the biopharma industry or academia
Experience leading study concept and protocol design, regulatory filings, clinical publications, and presentations
Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership
Strong scientific acumen as demonstrated through past experience and/or academic research
Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects
Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials, or a strong desire to learn
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 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.
As Director of Clinical development in the Inflammation/Fibrosis therapeutic area, you will lead or support multiple components of clinical trial programs, including primary biliary cholangitis (PBC) and/or other indications. You will be expected to provide scientific and clinical leadership or input on activities including study protocol preparation, other study or investigator documentation, medical monitoring, data analysis plans, study reporting, and clinical development input into regulatory documentation, publications, and scientific presentations. The ideal candidate will have a strong scientific acumen; This is a site based position at our Global Headquarters in Foster City, CA.
Lead or support clinical trial protocol design, clinical study report development, and response to health authority inquiries
Serve as medical monitor for clinical trials or oversee medical monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional team
Provide scientific and clinical guidance to cross-functional team members and colleagues to meet clinical development project deliverables and timelines
Lead or support the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products
Lead or support clinical development contributions in the preparation/review of regulatory documents, investigator brochures, and development plans
Lead or support the collection and interpretation of data for internal analysis and review, ensuring high quality data and appropriate analyses performed
Provide scientific and clinical leadership in the preparation, review, and interpretation of clinical trial data
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
We are all different, yet we all use our unique contributions to serve patients. MD or equivalent with 4+ years’ clinical, scientific and/or drug development experience in the biopharma industry, academia, or a related environment
Board certification in hepatology, gastroenterology is preferred; however, other backgrounds including pulmonology, rheumatology, or other internal medicine 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 is preferred, with clinical experience in medical monitoring and familiarity addressing medical concerns
Significant experience working on, with and leading cross-functional project/program teams in the biopharma industry or academia
Experience leading study concept and protocol design, regulatory filings, clinical publications, and presentations
Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership
Strong scientific acumen as demonstrated through past experience and/or academic research
Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects
Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials, or a strong desire to learn
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
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*. 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 for assistance.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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 apply via the Internal Career Opportunities portal in Workday.
Full Time/Part Time Full-Time
Remote Type Onsite Required
Click below to return to the Gilead Careers site
Click below to return to the Kite, a Gilead company Careers site