Director, Clinical Development (MD) Inflammation/Fibrosis
: Job Details :

Director, Clinical Development (MD) Inflammation/Fibrosis

Locations: United States - California - Foster CityTime Type: Full timePosted on: Vor 17 Tagen ausgeschriebenJob Requisition ID: R0042616

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 fulfill their aspirations. Join Gilead and help create possible, together.

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 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 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 the 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: $255,425.00 - $330,550.00. 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: Gilead Benefits Information.

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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.

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