Lead a team of diagnostic operations professionals to implement clinical biomarker and diagnostic plans for therapeutic programs in early and late-stage clinical development
Line management, training, oversight, and retention of diagnostic operations professionals
Maintain knowledge of the science, technology, portfolio, and strategy of R&D across Oncology and deliver high-quality diagnostic operations support
Engage with and influence leaders and cross-functional stakeholders to develop diagnostic operational strategies by leveraging broad knowledge of biomarker technologies, diagnostic development, IVD expertise, and global diagnostic regulatory requirements
Serve as a key strategic liaison with stakeholders across Clinical Operations, Central HBSM, Biobank, Data Management, Procurement, Regulatory, and Quality Assurance; work to improve cross-functional processes across GSK
Contribute to the continued building of a framework within the Operations function focusing on growth and development of new and “innovative” ways to work with internal and external partners
Lead functional process and system improvements to ensure operational excellence
Proactively support developing and reviewing standard processes and templates
Apply and adhere to ICH/GCP, HBS management best practices, regulatory guidelines, ethical guidelines, and technical and industry standards during all aspects of work, ensuring inspection readiness by ensuring preparedness and compliance; support team members in connection with inspections and audits
Represent the Dx Planning & Execution department internally and externally in meetings and discussions as required, and ensure representation of the Dx Delivery team during cross-functional workstreams
Set a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels by role modelling the GSK values

Requirements

MS or PhD degree in biological sciences or related discipline
Minimum of 10 years of experience in the diagnostic, pharmaceutical, or biotech industry
5+ years managing an Operations team
Strong background in Oncology
Experience with drug discovery and development, clinical trial design, and principles of clinical development
Experience in strategic set-up of central laboratory operations, study start up, clinical sample tracking/reconciliation and analysis
Experience in discovery, development, outsourcing, and validation of clinically applicable BMx and Dx assays, including clinical validation and global diagnostic regulatory submissions

Benefits

health care and other insurance benefits (for employee and family)
retirement benefits
paid holidays
vacation
paid caregiver/parental and medical leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical biomarker plansdiagnostic plansdrug discoveryclinical trial designclinical development principlescentral laboratory operationsclinical sample trackingBMx and Dx assaysclinical validationglobal diagnostic regulatory submissions

Soft Skills

leadershipteam managementtraininginfluencecross-functional collaborationstrategic thinkingprocess improvementinnovationcommunicationmotivation

Certifications

MS degreePhD degree