Associate Director, Virology Clinical Development (MD)
Gilead Sciences
Summary
The Associate Director, Virology Clinical Development (MD) plays a key role in the clinical development of therapies within the Virology Therapeutic Area. As a physician member of a multidisciplinary development team, this position contributes to the planning, execution, oversight, analysis, and reporting of clinical studies across multiple stages of development.
Job description
The role provides scientific and medical expertise to support clinical development strategies, study conduct, regulatory submissions, data interpretation, and scientific communications. The successful candidate will collaborate closely with cross-functional partners and external stakeholders to help advance innovative treatments 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
- 5+ Years with PhD/PharmD OR 2+ Years with MD in a relevant scientific, medical, or healthcare discipline.
- Ability and willingness to work on-site at the Foster City, California campus. This position is not eligible for remote work.
Preferred Qualifications
- MD or DO degree preferred, with training and/or experience in HIV medicine, Infectious Diseases, and/or HIV clinical research.
- Exposure to clinical research through academic, fellowship, investigator-initiated, translational, or industry-sponsored studies is preferred.
- Interest in HIV clinical drug development and clinical trial design, with a demonstrated desire to develop 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.
Requirements
- 5+ Years with PhD/PharmD OR 2+ Years with MD in a relevant scientific, medical, or healthcare discipline.
- Ability and willingness to work on-site at the Foster City, California campus.
- MD or DO degree preferred, with training and/or experience in HIV medicine, Infectious Diseases, and/or HIV clinical research.
- Exposure to clinical research through academic, fellowship, investigator-initiated, translational, or industry-sponsored studies is preferred.
- Interest in HIV clinical drug development and clinical trial design.
- 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.
- Foundational understanding of the drug development process and clinical research.
- 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.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Paid Time Off
- Annual Bonus
- Stock-based Long-term Incentives
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.