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Executive Director, Clinical Research (MD) Liver

Employer
Gilead Sciences, Inc.
Location
Times Square, WA
Closing date
Sep 23, 2022

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Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Job Description

You will lead a portfolio of clinical trial programs in Liver Fibrosis clinical development, including nonalcoholic steatohepatitis (NASH) and/or primary sclerosing cholangitis (PSC), for the assigned molecules / products. 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 therapeutics in targeting fibrosing ILDs.
  • 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.
  • 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 gastroenterology and/or hepatology is preferred, including familiarity with chronic liver diseases.
  • Regarded 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.

For Colorado Job Applicants: The salary range for this position is:

$275,280.00 - $412,920.00

Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.

Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

For jobs in the United States:

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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)

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.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
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