Director, Clinical Development (MD)
PharmaBiotechClinical ResearchRegulatory Affairsmedicalbiostatisticsemafdacroinformaws
Job description
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 Key Responsibilities Provide clinical and scientific leadership for one or more inflammation development programs. Develop and continually refine the Clinical Development Plan (CDP), including indication strategy, target populations, clinical sequencing, success criteria, and key development decisions. Lead the design and execution of early- and mid-stage clinical trials, including Phase 1b/2 proof-of-concept and dose-ranging studies. Translate complex immunology and human disease biology into testable clinical hypotheses and development strategy. Integrate clinical, translational, biomarker, pharmacologic, and competitive data to inform asset strategy and decision-making. Provide medical leadership for protocols, eligibility criteria, endpoints, safety monitoring, dose selection, and benefit-risk assessment. Partner closely and proactively with Clinical Operations, Biostatistics, Clinical Pharmacology, Translational Medicine, Research, Regulatory Affairs, Safety, Medical Affairs, and Commercial colleagues. Represent Clinical Development on cross-functional asset teams and contribute to governance presentations and development recommendations. Build and share institutional knowledge across the portfolio, contributing expertise beyond a single asset so that learnings, assumptions, and strategy are aligned across programs rather than siloed. Develop productive relationships with investigators, external scientific experts, and key opinion leaders. Contribute to regulatory strategy and health authority interactions, including preparation and review of clinical sections of regulatory documents. Qualifications Required MD, PhD, or equivalent advanced degree, with 6+ years of relevant experience in biopharmaceutical clinical development or academic clinical research. Demonstrated expertise in immunology, inflammation, or immune-mediated disease. Significant experience in biopharmaceutical clinical development and/or highly relevant academic clinical investigation. Experience designing, conducting, and interpreting interventional clinical trials. Strong command of trial design, endpoints, statistics, safety assessment, and drug development principles. Ability to critically evaluate emerging biological and clinical data and convert it into clear development decisions. Demonstrated success working through multidisciplinary teams and influencing without direct authority. Strong written and verbal communication skills, including translating complex science for non-specialist audiences. Comfort operating in a rapidly evolving environment where strategic and scientific questions remain open. Preferred Clinical or development expertise in pulmonary/respiratory medicine or dermatology, ideally asthma, COPD, atopic dermatitis, hidradenitis suppurativa, or related inflammatory disease. Board certification or advanced training in pulmonary medicine, allergy/immunology, dermatology, rheumatology, or a related specialty. Experience developing small molecules and/or novel targeted modalities in immune-mediated disease. Experience spanning first-in-human through proof-of-concept and Phase 2, including dose selection and evidence-generation strategy. Experience developing and applying pharmacodynamic, translational, or patient-selection biomarkers. Experience contributing to INDs and FDA or global regulatory interactions. The salary range for this position is: $261,375.00 - $338,250.00. 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: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. 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 fo
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