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Executive Director – Viral Hepatitis

Executive Director – Viral Hepatitis

Gilead Sciences, Inc.Foster City, CA, United States
18 days ago
Job type
  • Full-time
Job description

Executive Director – Viral Hepatitis

United States - California - Foster City Clinical Development & Clinical Operations Regular

Job Description

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

Executive Director – Viral Hepatitis

At Gilead, we are driven to develop lifesaving products that make a difference for patients around the world. Every day, we transform the promise of science and technology into breakthrough, innovative therapies that have the power to cure, prevent or treat disease. As a research-based biopharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including virology, respiratory diseases, liver diseases, hematology and oncology, and inflammation. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.

POSITION OVERVIEW :

This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for HBV and HDV infection. The Executive Director, Clinical Development, position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical HBV and HDV medicine. You will lead a portfolio of clinical trial programs in virology clinical development for viral hepatitis. You may act as or oversee other Development Leads 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.

KEY RESPONSIBILITIES

The executive director will play a key role in all stages of development for product programs from the drug discovery stage through product registrations worldwide.

  • Strategic input and oversight for ongoing and planned product trials / collaborations within the viral hepatitis portfolio
  • Strategic input and oversight of the HDV programs
  • Strategic input into the HDV and HBV cure programs
  • Develop and execute Phase 1, 2, and 3 clinical trials and provide scientific expertise
  • Serves as a member of the hepatitis leadership team
  • Report to VP of Hepatitis / Respiratory and Emerging Viruses who has direct responsibility for the overall strategy, clinical and scientific development activities

EXAMPLE RESPONSIBILITIES :

  • Leadership role in clinical strategy and execution of all hepatitis treatment, cure studies, translational programs, and research collaborations with close relationships with the research team
  • Key member of a team responsible for all scientific aspects of conceptualizing, planning, and executing trials.
  • Routinely 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.
  • Provides 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.
  • Key insight and involvement in the 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.
  • Provides scientific and clinical guidance to Research, Biology, Virology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.
  • Typically manages a team of direct reports.
  • May lead two or more specific components of organizational strategic initiatives.
  • 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.
  • Experience in viral hepatitis is preferred; however experience performing clinical research studies in those with chronic liver diseases, inflammation / fibrosis, immunology is also considered.
  • 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.
  • Extensive experience taking the lead on clinical study plans, protocol design, regulatory filings, clinical publications, and presentations.
  • Line management (direct reports) experience is required.
  • Extensive experience interacting with and presenting to executives is strongly preferred.
  • Demonstrated excellence leading 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 leadership skills with an ability to set vision, lead change, and mentor others.
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
  • 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 Gilead Difference

    Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it’s just what we do that gives us an edge, it’s how we do it. We expect everyone at Gilead to lead by example, guided by our core values :

  • Integrity – Doing What’s Right
  • Inclusion – Encouraging Diversity
  • Teamwork – Working Together
  • Accountability – Taking Personal Responsibility
  • Excellence – Being Your Best
  • The salary range for this position is : $324,615.00 - $420,090.00. 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.

  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
  • 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.

    Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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    Executive Director • Foster City, CA, United States

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