Director, Clinical Development (MD) Inflammation/Fibrosis

Director, Clinical Development (MD) Inflammation/Fibrosis United States - California - Foster City Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Making an impact on a global scale Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly CreatingPossible For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. 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 POSITION OVERVIEW: 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 metabolic dysfunction-associated steatohepatitis (MASH). 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. 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: 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 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. Minimum Education & Experience 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 Knowledge & Other Requirements 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 oral and written communication 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 The salary range for this position is: $255,425.00 - $330,550.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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 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. 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 ApplicantAccommodationsgilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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 to apply for this job. jeid-0b521cb1f5672a4f96f0d4a3a6f14ca1