Site Director overseeing AM & PM activities for the ASES program. Responsible for student safety, staff supervision, and maintaining program standards.
About the role
- Lead a team implementing clinical biomarker and diagnostic plans for therapeutic programs in Oncology. Oversee diagnostics execution supporting clinical trials and collaboration with cross-functional teams.
Responsibilities
- 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
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