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Senior Director, Program Management - Post Diagnosis Applications
Posted on 2/1/2022
INACTIVE
Locations
Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Management
R
Requirements
  • 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
  • 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
Responsibilities
  • 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
Desired Qualifications
  • Project Management Certification (PMP or equivalent) is a plus
GRAIL

501-1,000 employees

Designs cancer screening tests
Company Overview
GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
Benefits
  • Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
  • Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
  • Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
  • Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
Company Values
  • Grit - We are determined and resilient because patients are counting on us.
  • Respect - We value diversity and challenge each other respectfully.
  • Accountability - We own our decisions and keep our commitments.
  • Integrity - We adhere to our principles of humility, transparency, and rigor.
  • Leadership - We make each other better by making leadership everyone’s responsibility