CoFactor Recruitment · 1 day ago
Program Leader - Neuro
CoFactor Recruitment is a clinical-stage biotechnology company developing a novel therapeutic for neurodegenerative diseases. They are seeking an experienced Program Lead to oversee execution, integration, and strategic planning of its lead development program.
Responsibilities
Drive overall program strategy, timelines, scenario planning, and risk mitigation for early-stage clinical development
Develop and maintain an integrated program plan covering clinical, regulatory, CMC, nonclinical, and budget workstreams
Define program goals, critical paths, and key decision points across functions
Act as the primary integrator across internal functions including Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and Finance
Lead cross-functional team meetings, ensuring accountability, clarity of deliverables, and timely execution
Identify interdependencies and proactively resolve issues that may impact timelines, quality, or budget
Track progress against program milestones and provide clear, data-driven updates to executive leadership
Establish KPIs, dashboards, and operational metrics to support program visibility and predictability
Support planning for protocol development, study startup, regulatory submissions, data monitoring activities, and future trial readiness
Support regulatory interactions and submissions, including IND-related updates and briefing materials
Partner with Clinical Development and Clinical Operations on feasibility assessments, Phase 1b planning, and scenario analysis
Ensure alignment between scientific strategy and operational execution
Lead scenario planning related to timelines, enrollment assumptions, and spend forecasts
Partner with Finance and functional leads to maintain accurate program budgets and forecasts
Identify program risks, develop mitigation strategies, and communicate impacts clearly to leadership
Serve as a central point of coordination for external partners such as CROs, consultants, and advisors when cross-functional oversight is required
Support preparation of materials for Board meetings, scientific advisory meetings, and investor communications
Qualification
Required
Bachelor's degree required
8–12+ years of program or project leadership experience in biotech or pharmaceutical settings
Demonstrated success leading complex, cross-functional programs with competing priorities
Strong understanding of drug development processes across clinical, regulatory, nonclinical, and CMC domains
Excellent communication, organization, and meeting facilitation skills
Ability to translate complex technical information into clear plans and actionable decisions
Comfortable operating in a small, fast-paced, resource-constrained environment
Preferred
advanced degree in life sciences or related discipline
Experience supporting early-stage clinical development (Phase 1 / 1b)
Experience in neurology, neurodegenerative disease, rare disease, or CNS therapeutics