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Executive Director Clinical Development, Inflammation Therapeutics
3 months ago
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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 fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
POSITION OVERVIEW:
You will lead a portfolio of clinical trial programs in Liver Inflammation & Fibrosis clinical development, including primary biliary cholangitis (PBC), and/or metabolic dysfunction-associated steatohepatitis (MASH) for the assigned molecule(s) / product(s). The ideal candidate would have a strong clinical background in hepatology, along with experience in drug development. You may act as or oversee other Clinical Development Leads and Physician Responsible across the assigned project portfolio. You will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across your project portfolio. You will lead or otherwise oversee and direct the development, implementation and execution of the clinical development strategy for the assigned molecules / products, which will include development of the Target Product Profile and Clinical Development Plan. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
EXAMPLE RESPONSIBILITIES:
Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules/productsRoutinely represents the assigned molecules / products in cross-functional steering and /or governance committees.May lead the Global Development Team (GDT) for assigned molecules and / or assign GDT leadership to direct reports to ensure clinical development project deliverables and timelines are consistently met.May act as a core team member on the Program Strategy Team or assign this role to direct reports to ensure appropriate clinical development input and direction into the full lifecycle management of assigned products.Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products.In general, serves as the lead for communications, both written and oral, with health authorities, including but not limited to those clinical development activities relevant to global registration for assigned molecules/productsProvides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and 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. Where applicable, takes a lead on authoring scientific publications.May assist in the clinical evaluation of business development opportunities.Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for multiple molecules, the disease or therapeutic area overall.Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.Typically manages a team of direct reports.
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 8+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment. Board certification in hepatology, gastroenterology, or other inflammation-based expertise (eg, rheumatology, pulmonology) with a strong familiarity with chronic liver diseases including PBC/MASH is preferredRegarded as a thought leader in chronic liver diseases and fibrosis.Experience in the biopharma industry is strongly preferred.Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia, including short- and long-range strategic planning, governance and oversight.Multiple years' line management (direct reports) experience is preferred.Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences, healthcare, consulting or academia.
Knowledge & Other Requirements
Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.When needed, ability to travel.
The salary range for this position is: $341, $441, 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:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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For Current Gilead Employees and Contractors:
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