Assoc Clinical Development Director (MD) (United States - California - Foster City)
$226.19k - $292.71kGilead Sciences Inc.
This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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 DescriptionWe are seeking a highly motivated Associate Director- Clinical Development (MD) to be based in Foster City.
In this role, you will contribute to multiple aspects of clinical development programs in virology, with a focus on hepatitis. Working as part of a cross-functional team, you will support the planning, execution, monitoring, and interpretation of clinical studies. For assigned projects, you will contribute to a range of clinical trial activities, including study protocol development, investigator and study-related documentation, medical monitoring activities, data review and interpretation, study reporting, regulatory submissions, scientific publications, and presentations. This role provides an opportunity to gain broad experience across the clinical development process while helping advance innovative therapies for patients with viral diseases.
KEY RESPONSIBILITIES:
- Provides scientific and clinical expertise to cross-functional teams to support clinical development project deliverables and timelines.
- Contributes to the development and review of clinical trial protocols, clinical study reports, and responses to health authority inquiries.
- Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Contributes to the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, and development plans.
- Supports the collection, review, and interpretation of clinical data for internal analysis and decision-making.
- Manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Presents scientific and clinical information at investigator meetings, internal forums, and scientific conferences.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Basic qualifications:
- MD/DO or equivalent
Preferred qualifications:
- Training and/or experience in Hepatology (including in hepatitis B and/or D), Infectious Diseases, Immunology, or a related medical specialty is preferred.
- Exposure to clinical research through academic, fellowship, investigator-initiated, translational, or industry-sponsored studies is preferred.
- Interest in clinical drug development and clinical trial design, with a demonstrated desire to build expertise in these areas.
- Experience presenting scientific or clinical data through publications, abstracts, posters, presentations, or other scholarly activities is preferred.
- Experience collaborating across multidisciplinary teams in academic, clinical, research, or industry settings is preferred.
Additional Qualifications:
- Demonstrated ability to learn quickly and apply new concepts in a fast-paced environment.
- Demonstrated flexibility and adaptability, with the ability to manage multiple priorities and contribute across projects as needed.
- Strong analytical and critical thinking skills, as evidenced through clinical practice, research, academic training, or other professional experiences.
- Foundational understanding of the drug development process and clinical research, or a strong interest and aptitude for learning these areas.
- Familiarity with FDA and EMA regulations, ICH guidelines, GCP, and standard clinical research principles is preferred but not required.
- Strong scientific and medical knowledge, with the ability to critically evaluate and interpret clinical and scientific data.
- Excellent communication, presentation, organizational, and interpersonal skills.
- Ability to work effectively in a collaborative, cross-functional environment.
- Willingness and ability to travel as needed.
- 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:
* 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 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 View email address on apply.placed-app.com for assistance.
For more information about equal employment opportunity protections, please view the <
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