Director, Clinical Development (MD)

Описание вакансии

At Gilead Sciences, we’re driven by our mission to discover, develop, and deliver innovative therapeutics that improve the lives of patients worldwide.

Job Description

You will typically lead multiple components of clinical trial programs in immunology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable for 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 is a site-based role at our global headquarters in Foster City, CA. We offer a hybrid environment with optional Mondays and Fridays the ability to work from home.

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 2+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Experience in phase 1 and 2 clinical trials is preferred.
• Board certification in rheumatology/dermatology/gastroenterology or allergy and immunology is preferred, including familiarity with systemic autoimmune diseases.
• Experience in the biopharma industry is preferred.
• Experience leading small cross-functional project teams in clinical research or development.
• Experience taking the lead on study concept and protocol design, regulatory filings, medical monitoring, clinical publications and presentations is preferred.
• Proven effectiveness managing clinical project deliverables through matrix management.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.