Director, Diagnostics

GSK•Upper Providence Township, PA

About The Position

This Diagnostic Lead role will implement Dx development GSK Development wide encompassing technical, development, regulatory, commercial, and business development efforts by leading Dx projects and work streams according to agreed deliverables, timelines and budget. In this role, you will have the opportunity to lead the development and commercialization of diagnostics for GSK Oncology portfolio. You will have the responsibility to deliver on the vision of equipping GSK to be a leader through innovation and Dx development driving value by treating the right patient with the right medicine.

Requirements

Ph.D. in Biological Sciences and 5 years of pharmaceutical and/or diagnostic industry experience or B.S or M.S. with 7 years of pharmaceutical and diagnostic industry experience
Experience in drug / diagnostic development especially late stage development, regulatory approval and life cycle management (eg follow on Dx)
Experience with technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)
Experience in IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements
Experience performing due diligence and audit of Dx developers
Experience with GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
Experience with QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
Experience with clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management)
Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as MS Teams

Nice To Haves

Hands on experience in drug / Dx development
SAP development and diagnostic analysis required to support regulatory submissions
Management in a highly matrixed organization
Dx development and submission experience globally
Building and driving to success of high performing team
Must be detail oriented with strong organization skills in order to manage and meet deliverables
Demonstrate exceptional written and verbal communication skills

Responsibilities

Manage the team of associate directors, diagnostics. Team manager to deliver on the vision of equipping GSK to be a leader in oncology through Dx development driving the portfolio value
Monitor and report projects progress, outcomes, KPIs eg delivery of Target Diagnostic Profile
Remove barriers to Dx strategy development and implementation, collaborating cross functionally with clinical operations, external engagement, procurement, etc…
Exhibits timely management and delivery of projects/work streams within agreed budget .
Must be able to manage multiple projects and work streams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team’s objectives.
Clearly and concisely report project progress and outcomes, coordinating with project management, finance and business operations
Ensure learnings and best practices are shared and adopted for effective delivery
Participate in the evaluation of advanced technologies for IVD and clinical biomarker development
Keep a pulse on team execution and cross-functional ways of working with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams
Provides frequent project status updates / reports related to Dx deliverables.
Where applicable, accountable for implementing key organizational process improvement initiatives in daily activities