What the buyer needs

AI summary

The National Institute of Neurological Disorders and Stroke requires a Senior Advisor 2 Subject Matter Expert with patient advocacy expertise to support its Ultra-rare Gene-based Therapy Network. The contractor will serve on the External Counselor Board, advise on drug discovery and development milestones for nervous system conditions, evaluate project progress, and recommend solutions for programmatic challenges. Work will be performed offsite, requiring a minimum of 20 hours of annual support, with potential travel within the contiguous United States. Eligibility is restricted to total small businesses based in the United States. Key personnel must possess senior or executive-level experience in managing biotherapeutic discovery, at least 10 years of experience providing executive product development guidance to biotechnology or start-up companies, and at least 8 years directing multi-institutional research efforts. The contract term is one year, and offsite computer systems must meet specified NIH IT security and encryption standards.

Scope of work

Serve as member of URGenT External Counselor Board
Provide recommendations on gene-based and transcript directed therapy trials
Advise on collaborative research and biologic drug discovery for nervous system conditions
Advise on suitability and relevance of proposed product development milestones
Evaluate project progress relative to established milestones
Analyze potential opportunities and concerns for future URGenT program projects
Recommend potential solutions to resolve programmatic challenges
Submit written meeting notes and quarterly reports

Minimum qualifications

PhD or MD equivalent in a Biological Science or Drug Development-related discipline specializing in patient advocacy
Senior director level or executive level experience managing biotherapeutic discovery and development projects in biopharmaceutical industry or academia
At least 10 years executive-level experience providing product development guidance to government agencies, academic institutions, or start-up companies
At least 10 years experience with responsibility for operations and budgets
At least 8 years experience directing collaborative research efforts involving multiple institutions or teams
Knowledge and understanding of global regulatory regulations and guidelines

Documents to include with your response

Signed NIH non-disclosure agreement
Section 508 compliance statement or exception justification