Director – Packaging Technology
Sanofi
Executive Director, Diagnostics
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Upper Providence • Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Act as a Diagnostics (Dx) leader to deliver on the vision of equipping GSK to be a leader in precision medicine through Dx development driving value by identifying the right patient for the right medicine
- Lead, manage, and develop a Dx team comprised of senior talent
- Participate in leadership meetings to create cross-functional Precision Medicine strategies.
- Develop enterprise-wide Dx strategies that can benefit multiple GSK assets across therapeutic and vaccine areas.
- Define the Dx strategy from an asset perspective to support global drug registration
- Lead the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
- Be accountable for all aspects of Dx development with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
- Oversee all technical aspects of development, assay validation and clinical implementation of the selected assays; Authoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, PMA, IVDR and all other regulatory submissions
- Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements
- Ensure team exhibits timely management and delivery of projects/work streams within agreed budget
- Must be able to manage multiple projects and workstreams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team’s objectives
- Maintain an up-to-date knowledge of all assigned projects, strategy and progress. Clearly and concisely report projects progress and outcomes
- Ensure learnings and best practices are shared across R&D
- Liaises with: Project teams, EDLs, DPU heads, TA heads, and Platform team leaders
- Work with regulatory, policy, BD, TAs and business unit colleagues and key leadership within project teams
- Work with project leads to ensure efficient implementation of all key deliverables
Requirements
- PhD in the Biological Sciences with experience in the pharmaceutical and/or IVD industry or B.S or M.S. with pharmaceutical and/or IVD industry experience.
- People management experience leading a team directly and global cross-functional matrix teams
- Experience defining Dx strategy from an asset perspective to support global drug registrations
- Experience leading the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
- Experience developing the Dx strategy with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
- Experience in overseeing all technical aspects of development, assay validation and clinical implementation of the selected assays; Authoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, PMA, IVDR and all other regulatory submissions
Benefits
- US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Dx developmentassay validationclinical implementationbiomarker strategyregulatory submissionsIDEPMAIVDRclinical protocolsclinical study reports
Soft skills
people managementleadershipcross-functional collaborationproject managementcommunicationstrategic thinkingteam developmentbudget managementreportingproblem-solving
Certifications
PhD in Biological SciencesB.S. in Biological SciencesM.S. in Biological Sciences
