Sr Director, Clinical Development Inflammation and Fibrosis (MD)

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 DescriptionYou may act as a Clinical Development Lead and Physician Responsible on clinical trial programs in the Inflammation and Fibrosis therapeutic area. Clinical development activities include molecules / products targeting primary biliary cholangitis (PBC), other cholangiopathies, and metabolic dysfunction-associated steatohepatitis (MASH). The ideal candidate would have a strong clinical background in hepatology, along with experience in drug development.  As Clinical Development Lead, you will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials for the assigned molecules /products. You may take the lead on the development, implementation, and execution of the clinical development strategy for the assigned molecules / products, which will include constructing Clinical Development Plans and contributing to Target Product Profile development. Additional responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations. He/She will lead meetings with academic study investigators, key advisory meetings, and may participate in interactions with regulatory health authorities. This person will interact closely with the therapeutic area's senior management team.EXAMPLE RESPONSIBILITIES: Integrates with a team providing matrix leadership that ensures execution of innovative, highly proficient and feasible strategies for drug development specific to a portfolio of therapeutics targeting inflammatory & fibrotic diseasesSeeks to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solvingWill serve as a scientific and clinical resource with the liver fibrosis organization at GileadWorks closely with cross-functional leaders and teams to develop, implement, and oversee the clinical development strategy for the assigned molecules / productsRoutinely represents the assigned molecules / products in cross-functional steering and /or governance committeesMay lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules / productsMay lead the Global Development Team for assigned molecules; providing scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelinesMay act as a core team member on the Program Strategy Team, which is responsible for the full lifecycle management of the assigned productsLeads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / productsIn general, serves as the lead for communications, both written and oral, with health authoritiesProvides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillanceWill be part of a team responsible for the preparation/review of regulatory documents including but not limited to IND annual reports, IND safety reports, investigator brochures, and development plans, as well as managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections. May directly manage or delegate and oversee the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentationsPresents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publicationsMay assist in the clinical evaluation of business development opportunitiesDevelops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for assigned molecules /productsAdheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPsMay also manage one or more direct reportsREQUIREMENTS: 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 6+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment. Board certification in hepatology, gastroenterology is preferred; however, other inflammatory backgrounds including pulmonology, rheumatology, immunology with experience performing clinical research studies in those with chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also considered.Experience in the biopharma industry is strongly preferred.Multiple years’ experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia.Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.Multiple years’ line management (direct reports) experience is preferred.Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.Demonstrated excellence leading large and complex teams in life sciences, healthcare, consulting or academia.Knowledge & Other Requirements Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.Ability to think analytically and strategically to formulate, develop, and execute clinical plansStrong leadership skills with an ability to set vision, lead change, and mentor othersWhen needed, ability to travel.The salary range for this position is: $295,290.00 - $382,140.00. 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: * 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 ApplicantAccommodations@gilead.com for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.SummaryLocation: United States - California - Foster CityType: Full time