Director, Diagnostics

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.

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 teams 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

Basic Qualifications:

• 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

Preferred Qualifications:

• 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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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Director