Assoc Clinical Development Director (MD)

Gilead Sciences•Foster City, CA

2d•$226,185 - $292,710•Onsite

About The Position

We 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.

Requirements

MD/DO or equivalent

Nice To Haves

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.
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.

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.