Description
You will provide operational leadership for diagnostic activities across GSK's Antibody Drug Conjugate (ADC) portfolio, managing a team of Diagnostic Delivery Leads. You will be accountable for execution of biomarker and diagnostic strategies, including oversight of external testing partners and delivery of diagnostic milestones, to support clinical development, regulatory submissions, and diagnostic approvals.
Key Responsibilities:
- Manage operational delivery of biomarker and diagnostic activities for patient selection or stratification across the ADC portfolio.
- Provide operational leadership to diagnostic programs from assay development through regulatory approval.
- Lead relationships with external parties, including laboratories, CROs, central laboratories, and diagnostic manufacturers.
- Drive operational excellence, continuous improvement, inspection readiness, and compliance with GCP, GDPR, and global regulatory requirements.
Basic Qualifications:
- Relevant degree-level education (e.g., life sciences) and previous line-management experience.
- Relevant experience/knowledge of oncology diagnostic development, implementation, and operational delivery.
- Experience managing vendor relationships.
- Strong knowledge of biomarker-driven drug development, precision medicine, and global clinical development processes.
- Proficiency with digital tools, including Excel, PowerPoint, Word, SharePoint, Teams.
Preferred Qualifications:
- Advanced relevant scientific degree (e.g., M.S. or PhD).
- Experience supporting Antibody Drug Conjugate (ADC) development programs.
- Experience in companion diagnostic development and drug-diagnostic co-development.
- Knowledge of global In Vitro Diagnostic Medical Device Regulation (IVDR)/CDx regulatory requirements.
- Experience supporting regulatory submissions, inspections, and audits.