Director, Clinical Development Inflammation/Fibrosis (MD)United States - California - Foster City Clinical Development & Clinical Operations Regular
Job DescriptionAt 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 Responsibilities: You will typically lead multiple components of clinical trial programs in Inflammation/Fibrosis clinical development, which may include programs in early and late phase development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include but are not limited to study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations.
EXAMPLE RESPONSIBILITIES: Provides input into the Target Product Profile and Clinical Development Plan for assigned molecules/productsProvides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelinesProvides substantial input into - sometimes leading - clinical trial protocols, clinical study reports, and health authority inquiry responsesProvides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillanceManages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, and development plansWith cross-functional partners, coordinates the collection and assimilation of ongoing data for internal analysis and reviewWith cross-functional partners, coordinates and manages the preparation and/or review of data listings, summary tables, study results, and scientific presentationsPresents at scientific conferences and clinical study investigator meetings as needed and appropriateAdheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPsREQUIREMENTS: 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.
MD or equivalent with 4+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environmentWorking knowledge of fibroinflammatory and/or autoimmune pathology and pathobiology in a relevant clinical discipline, such as hepatology, pulmonology, rheumatology, dermatology, allergy, or immunology, with experience performing clinical research studies in patient populations with fibroinflammatory and/or autoimmune diseasesExperience in the biopharma industry is preferred, with clinical experience in medical monitoring and familiarity addressing medical concerns in the context of clinical trialsSignificant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting, or academiaExperience taking the lead on study concept and protocol design, publications, and presentations; experience contributing significantly to regulatory filingsDemonstrated excellence in effectively managing multiple clinical project deliverables and operating within matrixed management and leadership systemsKnowledge & Other Requirements: Proven analytical abilities as demonstrated through past industry and/or academic researchAbility to develop and/or maintain expertise in the assigned disease area(s), as evidenced by ability to independently lead clinical development contributions for one or more projectsWorking knowledge of pharmaceutical regulatory requirements and impact on development and execution of clinical trialsStrong communication and organizational skills, including ability to effectively communicate project direction and status to cross-functional counterparts at varying organizational levels and leadership teams/committees as necessaryIntermittent travel to conferences, investigator meetings, other external meetings as neededThe 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 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.
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