Director, Clinical Development (Md)

Gilead Sciences Inc.; Maryland; On-site; USD 261,000 - 338,000; Full time

Job summary

Gilead Sciences Inc. in the United States seeks a physician leader to drive multiple components of inflammation/fibrosis clinical programs, including PBC and MASH.

You will oversee study design, data analysis inputs, regulatory documentation, and scientific communications for late‑stage development. You will provide medical monitoring, cross‑functional guidance, and coordination of protocol design, study reports, and investigator presentations, with travel as needed.

Qualifications

• MD or equivalent with 4+ years' clinical, scientific and/or drug development experience in biopharma, healthcare, consulting, academia or related environment.
• Board certification in hepatology or gastroenterology preferred; other inflammatory backgrounds considered.
• Experience leading cross-functional project teams in life sciences or academia.
• Strong regulatory and medical monitoring expertise for clinical trials.

Responsibilities

• Leads development of Target Product Profiles and Clinical Development Plans for assigned molecules/products.
• Guides cross-functional teams to meet project deliverables and timelines.
• Contributes to protocol design, study reports, and health authority inquiries.
• Oversees medical monitoring and toxicity management in clinical trials.
• Coordinates data listings, summaries, and presentations of study results.
• Presents scientific information at conferences and investigator meetings.

Skills

MD/DO

Clinical development

Regulatory filings

Cross-functional leadership

Data analysis

Publications

Hepatology

Trial monitoring

Education

Board certification in hepatology/gastroenterology

Job description

Job Description

You will typically lead multiple components of clinical trial programs in Inflammation/Fibrosis clinical development, including primary biliary cholangitis (PBC), and/or metabolic dysfunction‑associated steatohepatitis (MASH). You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable or various aspects of ongoing clinical trial program‐related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations. This work will include the synthesis of data from Phase 3 and other studies, supporting activities linked to global registration of a late‐stage therapeutic in clinical development, including assisting in the execution of clinical postmarketing requirements, and other clinical development‐related commitments.

EXAMPLE RESPONSIBILITIES:

• Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
• Provides scientific and clinical guidance to cross‑functional teams and colleagues to meet clinical development project deliverables and timelines.
• Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and 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.
• Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
• Coordinates the collection and assimilation of ongoing data for internal analysis and review.
• Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific information at scientific conferences as well as clinical study investigator meetings.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• MD or equivalent with 4+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Board certification in hepatology, gastroenterology is preferred; however, other inflammatory backgrounds including pulmonology, rheumatology, immunology with experience performing clinical research studies in those with chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also considered.
• Experience in the biopharma industry is preferred, with clinical experience in medical monitoring and familiarity addressing medical concerns.
• Significant experience working on, with and leading cross‑functional project/program teams in life sciences, healthcare, consulting or academia.
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.

Knowledge & Other Requirements

• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
• Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• When needed, ability to travel.

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.

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