Roche
Diagnostics
ClinicalDevelopmentLead(Neuroscience)
“Clinical Development Lead (Neuroscience) at Roche. Skills: Clinical Strategy, Health Authority Interactions, Stakeholder Partnerships. Lead clinical development strategy for diagnostic studies. Define clinical utility, intended use, and claim extensions”
What You'll Achieve.
Bring medically-differentiated solutions to patients globally; Generate comprehensive clinical evidence; Facilitate smooth product registration, adoption and reimbursement globally; Save lives and improve patient quality of life
Industry & Context.
Analytical thinker
Willingness to travel up to 25%
What They're Looking For.
Must Have
Medical degree (MD) or an advanced degree (PhD) in Neuroscience or related fields, Established experience within academia, diagnostics, or the pharmaceutical industry, preferably in the neuroscience area, Demonstrated experience of designing and leading large, complex clinical development programs across all stages of the product development, Guiding cross-functional, matrixed teams, Deep understanding of applicable global standards and regulations, such as ICH-GCP, FDA, and NMPA, Experience with IVDD/IVDR and MDR
Nice to Have
Experience with IVDD/IVDR and MDR
What You'll Do.
Lead clinical development strategy for diagnostic studies
Define clinical utility
Work with Global Regulatory Affairs on submissions
Author critical sections of meeting packages
Review clinical documents for submissions
Act as clinical lead in external interactions
Build strategic relationships with Key Opinion Leaders
Drive development partnerships
Oversee communication strategies for clinical studies
Represent organisation at medical congresses
Act as key driver for competitive differentiation
Develop intellectual property strategies
Optimise clinical processes
Act as a dedicated coach for team members
How You'll Work.
Team & Collaboration
Partner effectively across diverse regions, cultures, and time zones; Foster an environment of belonging and collaboration; Collaborate with internal teams, external partners, and patients
Communication Scope
Communication excellence
Process & Methodology
Leading large, complex clinical development programs
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