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Sr. Director of Clinical Development (MD) - Liver

Employer
Gilead Sciences, Inc.
Location
Seattle, WA
Start date
Sep 24, 2022

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Job Details


You may act as a Clinical Development Lead and Physician Responsible for 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. As Clinical Development Lead, you will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials for the assigned molecules /products. You may take the lead on the development, implementation and execution of the clinical development strategy for the assigned molecules / products, which will include leading development of the Target Product Profile and Clinical Development Plan. Additional 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. You will lead meetings with academic study investigators, key advisory meetings, and may participate in interactions with regulatory health authorities. In this role, you will interact closely with the therapeutic area's senior management team.

EXAMPLE RESPONSIBILITIES:
  • Integrates with a team providing matrix leadership that ensures execution of innovative, highly proficient and feasible strategies for drug development specific to a portfolio of therapeutics targeting fibrosing ILDs
  • Seeks to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
  • Will serve as a scientific and clinical resource with the liver fibrosis organization at Gilead
  • Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.
  • Routinely represents the assigned molecules / products in cross-functional steering and /or governance committees.
  • May lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
  • May lead the Global Development Team for assigned molecules; providing scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
  • May act as a core team member on the Program Strategy Team, which is responsible for the full lifecycle management of the 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.
  • Will be part of a team responsible for the preparation/review of regulatory documents including but not limited to IND annual reports, IND safety reports, investigator brochures, and development plans, as well as managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections. May directly manage or delegate and oversee 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 assigned molecules /products.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
  • May also manage one or more 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 6+ 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.
  • Experience in the biopharma industry is strongly preferred.
  • Multiple years' experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia.
  • Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
  • Multiple years' line management (direct reports) experience is preferred.
  • Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
  • Demonstrated excellence leading large and complex teams in life sciences, healthcare, consulting or academia.


Knowledge & Other Requirements
  • Has an expert-level of knowledge of drug development, as evidenced by a proven track record in setting short- and long-range drug development strategies and plans.
  • Has a 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. Able to distill complex matters into a clear business case and roadmap for execution.
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans
  • Strong leadership skills with an ability to set vision, lead change, and mentor others
  • When needed, ability to travel.



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. 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' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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:

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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Find Us
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States
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