Director – Precision Diagnostics, Oncology
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts • Pennsylvania • United States
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Salary
💰 $189,750 - $316,250 per year
Job Level
About the role
- Development and execution of precision diagnostics strategy for oncology programs, spanning multiple assets and therapeutic areas.
- Define diagnostic requirements for trials and, in partnership with clinical teams, implement biomarker selection, assay validation, and biological sample collection/handling strategy.
- Oversee project plans, budgets, and timelines to ensure on-time, high-quality delivery of diagnostic milestones via cross-functional collaboration with project management, biomarkers, clinical & biomarker operations, external engagement, procurement, etc.
- Work with regulatory and quality teams to ensure diagnostic development meets regulatory expectations and requirements and in diagnostic regulatory submissions.
- Engage external partners, including diagnostic companies, clinical labs and technology vendors, to accelerate assay development and access to patient samples.
- Provide frequent project status updates and reports related to diagnostic deliverables in collaboration with project management, finance and business operations.
- Share learnings and best practices for diagnostic development and execution and participate in initiatives for key organizational process improvements.
Requirements
- Bachelor’s degree in life sciences, molecular diagnostics, clinical laboratory science, or related field. Advanced degree preferred.
- At least 8 years of experience in diagnostic development, biomarker strategy, and/or clinical assay development, with at least 2 to 3 years direct experience in oncology diagnostic development.
- Demonstrated experience integrating diagnostics into clinical trial design and familiarity with clinical trial design elements such as efficacy endpoints, biomarker testing, data management and human biological specimen management and operations.
- Knowledge of regulatory requirements for diagnostics or companion diagnostics and quality management systems, including FDA and EU medical device regulations and QSR regulations, GMP manufacturing, ISO13485, etc.
- Diagnostic protocol and analysis plan development required to support diagnostic development and regulatory submissions.
- Proven ability to manage cross-functional projects, timelines, and budgets in a matrix environment.
- Strong stakeholder management skills, including working with clinical teams, external partners and clinical laboratories.
- Demonstrated ability in clear, effective, cross-team, open communications and collaboration.
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
diagnostic developmentbiomarker strategyclinical assay developmentclinical trial designdata managementhuman biological specimen managementregulatory submissionsprotocol developmentanalysis plan developmentGMP manufacturing
Soft Skills
stakeholder managementcross-functional collaborationproject managementcommunicationorganizational skillsteam collaborationprocess improvementbudget managementtimeline managementproblem-solving