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Foster City, California, United States
Onsite
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
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
This role requires regular on-site presence in Foster City, CA and is not eligible for remote or hybrid work arrangements. Applicants must currently reside in the area or be willing to relocate to Foster City prior to their start date. Local candidates are strongly encouraged to apply.
The Senior Director, Clinical Development will provide clinical and scientific leadership for inflammation development programs, with particular emphasis on immune-mediated inflammatory diseases and dermatology. The successful candidate will play a key role in defining development strategy, translating emerging biology into clinical hypotheses, and designing clinical programs capable of generating clear, decision-enabling evidence.
This individual will work across functions and programs, helping shape both individual asset strategies and the broader inflammation portfolio. The role requires substantive experience establishing and leading Phase 2 development programs, with the strategic perspective needed to build programs that can transition efficiently into Phase 3 and support registration.
· Provide clinical and scientific leadership for one or more inflammation development programs, with opportunities spanning dermatologic, respiratory, and other immune-mediated diseases.
· Lead development and continual refinement of Clinical Development Plans (CDPs), including indication strategy, target populations, clinical sequencing, differentiation strategy, success criteria, and key development decisions.
· Lead the strategy, design, initiation, execution, and interpretation of Phase 2 clinical development programs, including proof-of-concept and dose-ranging studies, with an eye toward Phase 3 and registration.
· Own key elements of Phase 2 program development, including clinical strategy, protocol development, patient population, endpoints, dose and regimen selection, and medical input into site and investigator selection.
· Provide medical and scientific leadership during study start-up and execution, including investigator and site selection strategy, site initiation, investigator engagement, enrollment, protocol interpretation, and ongoing assessment of study conduct.
· Use emerging Phase 2 data to refine the development strategy and prepare successful programs for transition into Phase 3 and registrational development.
· Translate complex immunology, human genetics, translational science, and disease biology into testable clinical hypotheses and development strategies.
· Integrate clinical, translational, biomarker, pharmacologic, competitive, and emerging external data to inform asset and portfolio strategy.
· Provide senior medical leadership for protocols, eligibility criteria, endpoints, safety monitoring, dose selection, benefit-risk assessment, and interpretation of clinical data.
· Apply a strong understanding of dermatologic disease biology and clinical development to programs in areas such as atopic dermatitis, hidradenitis suppurativa, psoriasis, and related immune-mediated diseases, while contributing broadly across the inflammation portfolio.
· Identify opportunities for differentiation based on mechanism, patient population, clinical endpoints, treatment setting, and evolving standards of care.
· Partner closely and proactively with Clinical Operations, Biostatistics, Clinical Pharmacology, Translational Medicine, Research, Regulatory Affairs, Safety, Medical Affairs, and Commercial colleagues.
· Provide influential Clinical Development leadership on cross-functional asset teams and help drive program strategy, development recommendations, and governance decisions.
· Develop productive scientific relationships with investigators, external experts, and key opinion leaders, and use these relationships to refine clinical strategy and evidence-generation plans.
· Provide clinical leadership for regulatory strategy and health authority interactions across Phase 2 development and the transition to Phase 3, including end-of-Phase 2 discussions and preparation or review of clinical components of regulatory submissions.
· Mentor and develop clinical scientists and physicians and contribute to a strong scientific and clinical development culture.
MD, DO, PhD, or equivalent advanced scientific or medical degree.
10+ years of relevant clinical, scientific, and/or drug-development experience in industry, academia, or a combination of both, including substantial experience in clinical development and demonstrated leadership in establishing and executing Phase 2 clinical development programs, with experience contributing to or leading Phase 3 development.
· Direct experience developing Phase 2 clinical strategy and protocols, initiating and conducting Phase 2 interventional trials, and interpreting Phase 2 data to inform Phase 3 development strategy.
· Experience providing clinical input into investigator and site selection, study initiation, and ongoing medical leadership during trial execution.
· Expertise in immunology, inflammation, dermatology, or immune-mediated disease.
· Strong command of clinical trial design, endpoints, statistics, safety assessment, dose selection, benefit-risk evaluation, and drug-development principles.
· Demonstrated ability to critically evaluate emerging biological and clinical data and translate those data into clear development decisions.
· Demonstrated success leading through multidisciplinary teams and influencing senior stakeholders without direct authority.
· Strong written and verbal communication skills, including communicating complex scientific concepts and development recommendations clearly to senior leaders and non-specialist audiences. Clinical training, board certification, or substantial drug-development expertise in dermatology, allergy/immunology, rheumatology, pulmonary medicine, or a related specialty.
· Clinical development experience in atopic dermatitis, hidradenitis suppurativa, psoriasis, or related inflammatory diseases; experience in asthma, COPD, or other immune-mediated diseases is also relevant.
· Experience building Phase 2 programs from strategy and protocol development through study initiation and execution, and advancing programs from Phase 2 proof-of-concept or dose finding into Phase 3.
· Experience with global Phase 3 programs and regulatory interactions supporting late-stage development.
· Experience developing small molecules, biologics, and/or novel targeted modalities in immune-mediated disease.
· Experience developing and applying pharmacodynamic, translational, patient-selection, or disease biomarkers.
· Established relationships with investigators and external scientific experts in dermatology, immunology, or inflammatory disease.
• Create Inclusion – knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent – understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
• Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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.
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 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 ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
Please apply via the Internal Career Opportunities portal in Workday.
