This job has expired

You will need to login before you can apply for a job.

Senior Director, Post Authorization Studies (PAS) Lead

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Nov 18, 2022
You need to sign in or create an account to save a job.

Job Details

Senior Director, Post Authorization Studies (PAS) Lead
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.

Job Description


Specific Responsibilities:
  • Function as the Medical Monitor for Post Authorization Studies (PAS) that are assigned to PS for the purposes of regulatory commitments.
  • Collaborate with the SMEs for the products to assure an understanding of the necessary data to be collected and Adverse Events of Interest for the compound in the PAS.
  • Collaborate cross functionally in the PAS study design.
  • In collaboration with the CRO develop the medical monitoring plan (MMP) for the PAS.
  • Collaborate cross functionally and proactively if based on prior regulatory requests a PAS can be predicted to be necessary for marketing authorization.
  • For studies collecting data on the same compound look for opportunities to standardize the data collected and the methods of collection within the studies, to achieve efficiencies.
  • Contributes to preparation and review of safety documents, regulatory inquiries, study reports and SAP
  • Contributing to manuscripts, abstracts, and scientific presentations as necessary.
  • Participates in audits, data analysis, and other ad hoc activities.
  • Oversee CRO safety related activities to assure contractual agreements are being met and provide medical input on escalated issues as needed.
  • Communicate with compound SMEs regarding PAS progress for the purposes of aggregate reports, RMPs regulatory communications.
  • Contribute to PAS process improvements.


Essential Duties and Job Functions:
  • Provides medical safety oversight of the PAS, CRO and sign off on safety documents, collaborate within PS and cross functionally to ensure the studies meet the regulatory request and CROs meet contractual agreements.
  • Performs monitoring of the study CRO, medical evaluation of data as needed, review of study reports, medical monitoring plans and monitoring for safety signals.
  • Keep compound SMEs informed of the study progress, issues, and findings.


Knowledge, Experience and Skills:
  • Requires an MD/DO degree or equivalent
  • Requires completion of an accredited medical or surgical residency program. Board certification is preferred.
  • Should have an exceptional track record of excellence in clinical practice in a medical specialty
  • Should have an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
  • Ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously
  • Ability to develop cross functional relationships with RWE, Med Affairs, Clinical Operations, work with CROs, understand roles and responsibilities, and review data.
  • Necessary to have experience in post marketing pharmacovigilance, signal detection and evaluation, review of study reports, work collaboratively in a cross functional setting and attention to detail.
  • Preferred to have experience with drug approval and regional post authorization requirements.

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, Singapore, and Hong Kong 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:


Please log onto your Internal Career Site to apply for this job.






jeid-6382f4d057d3994999cf446de5670075

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
US
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert