Associate Medical Director, Clinical Science, NS TAU

POSITION OBJECTIVES:

• Lead and drive strategy for clinical studies within global clinical development for assigned pipeline compounds, considering medical, scientific, regulatory, and commercial issues.
• Lead/join multi-disciplinary, multi-regional matrix teams; integrate cross-discipline input to create, maintain, and execute studies within a clinical development plan for regulatory approval across regions.
• Influence Neuroscience Therapeutic Area Unit senior leadership strategic direction.

• Represent Clinical Science on study execution and clinical teams (may serve as co-leader); align activities with global strategy.
• May serve as Global Clinical Lead for early clinical stage or preclinical programs with translational/biomarker and preclinical partners.
• Develop and contribute to asset strategy, clinical development plans, clinical protocols and related documents; recommend scope/complexity/size and influence study/program budgets.
• Monitor and interpret internal/external study data; make recommendations including go/no-go decisions and plan/design modifications.
• Oversee synopses/protocol preparation/approval and interpret clinical study results; advise clinical scientists.
• Conduct trial medical monitoring: protocol conduct, subject safety, safety assessment with Pharmacovigilance; make final scientific integrity decisions.
• Lead key opinion leader interactions and incorporate KOL advice into study/program design.
• Evaluate business development opportunities/due diligence; support alliances and in-licensing clinical development plan negotiation and partner interfaces.
• Mentor/develop/retain staff; represent clinical science on task forces and cross-functional teams.

• MD or MD/PhD (or equivalent) plus 3 years clinical research experience in pharma/CRO/consulting/academia; matrix leadership preferred; first-in-human and early proof-of-concept trial design/execution preferred.

• Superior communication, strategic, interpersonal, negotiating; proactive issue prediction/problem solving; drive decisions in matrix teams; diplomacy/influencing.
• Neurology therapeutic area specialization preferred; neuromuscular/neurodegenerative subspecialty preferred; regional/global regulatory requirements; GCP/ICH.

• ~10-20% travel; hybrid work.