Senior Director of Benefits ensuring strategic design and operational excellence of Novavax’s benefit programs. Overseeing vendor relationships and compliance while leading a benefits team in a mission - driven company.
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
Director, Payments Specialist managing comprehensive payment strategies for FNBO. Leading business development and delivering innovative payment solutions to optimize client satisfaction.
Director of IT overseeing biometrics technology platforms for clinical development at Syneos Health. Ensuring secure, compliant solutions while driving strategic initiatives and operational excellence.
Director of US marketing strategies for Basil Hayden at Suntory Global Spirits. Leading brand's growth through impactful marketing in a competitive market.
Network Director guiding clinical engineering initiatives to enhance service and operational efficiency at TRIMEDX. Overseeing operations, compliance, and staff development at Jackson, MS location.
Director of Aviation responsible for growth of Aviation market at IMEG, a design consulting firm. Driving strategic initiatives and enhancing client relationships in the engineering sector.
Executive Director providing strategic leadership for IDD services at RHA Health Services. Overseeing clinical, administrative, and financial operations to ensure compliance and quality care.
Technical Director at Connected Logistics providing acquisition support, project management, and engineering services. Focusing on optimizing IT services and improving process efficiencies for AESMP.
Senior Director managing investor relationships for low - income housing investments. Leading investor strategy and overseeing investor relations processes within a nonprofit organization.
Director of Grants managing federal grant strategies for higher education clients. Collaborating with leadership and delivering results within fixed deadlines in a consulting firm.