Senior Director, Program Management - Post Diagnosis Applications

Employer
GRAIL, LLC
Location
Remote - USA or Raleigh-Durham, NC
Posted
Apr 20, 2022
Required Education
Bachelors Degree
Position Type
Full time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

Grail is hiring a highly motivated Senior Director, Program Management to lead a team in the development and execution of clinical trial assays to support pivotal pharma sponsored clinical trials, as well as leading the development of IVD products in partnership with biopharma. The successful candidate can be based in either the UK or US.
You Will:
  • Lead a cross-functional team in the development of a clinical trial assay and future CDx /IVD product in partnership with biopharma.  
  • Work closely with R&D, Quality, Regulatory, Product, Laboratory Operations, Software Engineering, Medical Affairs and other key departments throughout the development lifecycle. 
  • Establish and maintain functionally integrated project schedules to enable accurate project management.  
  • Drive team execution to the schedules and actively work with the team to resolve issues as they arise. 
  • Manage joint project team meetings with external partnersLead communications with pharma partners and their CROs to ensure alignment with program deliverables
  • Support business development in the creation of program plans and budgets and take responsibility for budget management throughout the project lifetime
  • Build and manage budgets for biopharma programs.
  • Work closely with finance partners to track and report progress for revenue recognition and expenditure
  • Communicate program updates to the team, to functional management and executive leadership
  • Ensure timely team completion of design history file documents throughout development
  • Schedule, organize, and drive team meeting(s): prepare and distribute agendas; track action items, and escalate areas of concern to the appropriate management entity
  • Lead the team to prepare for phase gate reviews and other go/no go decisions required by executive leadership

Your Background Should Include:
  • Minimum of a BA/BS in a scientific discipline is required, while an advanced degree is desirable in a discipline related to device, diagnostic, and/or drug development.
  • The ideal candidate will have at least 15 years multidisciplinary experience in the device/diagnostic/biotech industry, with at least 10 years of direct project management experience on interdisciplinary or cross functional product development teams ideally focused on clinical development of an in vitro /companion diagnostic, and at least 5 years of direct line management experience. 
  • Project Management Certification (PMP or equivalent) is a plus.
  • Experience working in FDA-regulated environments or clinical studies is required.
  • Experience leading teams to successfully launch medical devices or in vitro diagnostic products is highly desired.
  • Experience working and managing projects under design control is highly desired.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees 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.