Site Director overseeing AM & PM activities for the ASES program. Responsible for student safety, staff supervision, and maintaining program standards.
About the role
- Diagnostics Leader at GSK focusing on precise medicine innovations through diagnostics development. Overseeing global drug registration and collaboration across therapeutic areas with a team of senior talent.
Responsibilities
- Act as a Diagnostics (Dx) leader to deliver on the vision of equipping GSK to be a leader in precision medicine through Dx development driving value by identifying the right patient for the right medicine
- Lead, manage, and develop a Dx team comprised of senior talent
- Participate in leadership meetings to create cross-functional Precision Medicine strategies.
- Develop enterprise-wide Dx strategies that can benefit multiple GSK assets across therapeutic and vaccine areas.
- Define the Dx strategy from an asset perspective to support global drug registration
- Lead the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
- Be accountable for all aspects of Dx development with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
- Oversee all technical aspects of development, assay validation and clinical implementation of the selected assays; Authoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, PMA, IVDR and all other regulatory submissions
- Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements
- Ensure team exhibits timely management and delivery of projects/work streams within agreed budget
- Must be able to manage multiple projects and workstreams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team’s objectives
- Maintain an up-to-date knowledge of all assigned projects, strategy and progress. Clearly and concisely report projects progress and outcomes
- Ensure learnings and best practices are shared across R&D
- Liaises with: Project teams, EDLs, DPU heads, TA heads, and Platform team leaders
- Work with regulatory, policy, BD, TAs and business unit colleagues and key leadership within project teams
- Work with project leads to ensure efficient implementation of all key deliverables
Requirements
- PhD in the Biological Sciences with experience in the pharmaceutical and/or IVD industry or B.S or M.S. with pharmaceutical and/or IVD industry experience.
- People management experience leading a team directly and global cross-functional matrix teams
- Experience defining Dx strategy from an asset perspective to support global drug registrations
- Experience leading the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
- Experience developing the Dx strategy with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
- Experience in overseeing all technical aspects of development, assay validation and clinical implementation of the selected assays; Authoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, PMA, IVDR and all other regulatory submissions
Benefits
- US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Associate Director delivering client projects at Crosslake, focusing on technology governance and proactive management. Collaborating on strategic direction and project execution in a hybrid work environment.
Chair of the Board of Directors leading governance and strategic responsibilities at MaRS. Engaging with policymakers and fostering a high - performing Board.
Regional Sales Director managing a team of Cybersecurity Technical Account Managers. Responsible for driving revenue growth and developing customer relationships for a leading security solutions provider.
Lead NA Aladdin Business Manager driving strategic projects on Aladdin for Columbia Threadneedle Investments. Manage stakeholder relations, operational oversight, and deepen Aladdin usage across the organization.
Technical Program Manager accountable for delivery of CXM's client accounts at dentsu. Collaborates with client management and project teams across various service lines and practice areas.
Director of Contract Analytics at Sanofi guiding complex contract analysis and negotiations. Leading a team and ensuring alignment with corporate financial objectives in a hybrid setting.
Statistical Project Leader providing statistical leadership and innovative solutions in pharmaceutical clinical development. Leading statistician in project teams to support trial decision - making across all drug development phases.
Director of Cyber Defense at Sony leading a team for strategic cyber protection and incident response. Blending leadership with operational accountability in a global entertainment and technology giant.
Scientific Director providing clinical and scientific leadership in respiratory clinical development at GSK. Focusing on transformative medicines and ensuring clinical excellence and regulatory compliance.