Associate Director, CMC Lead
Core
Lead early-stage CMC strategy for alpha-emitting, tumor-targeted radioconjugates to enable first-in-human studies and clinical supply.
Role type
Senior IC Associate Director, CMC Lead
Builds
IND-enabling documentation, scalable phase-appropriate processes, and clinical supply for oncology radioconjugates
Domain
Biopharmaceuticals / Oncology / Radiopharmaceuticals
Required skills
CMC strategy, IND-enabling activities, API/Drug Product/Analytical development, clinical supply planning, portfolio management, cross-functional leadership, risk assessment, process development, analytical method development, matrix environment navigation
Preferred skills
Radiopharmaceuticals/radioconjugates expertise, IND/IMPD filing authorship, short half-life product supply, Quality by Design, tech transfer to GMP, analytical lifecycle management
Technologies
GMP facilities, CDMOs, radiopharmaceutical manufacturing
Responsibilities
Define pre-IND/IND-enabling CMC strategy; lead regulatory documentation for IND/IMPD submissions; coordinate API, drug product, and analytical development; build clinical supply strategies for Phase 0/I; manage multiple early-stage programs; represent CMC in cross-functional teams; assess new targets for CMC feasibility; enable transition from research to development
Seniority
Senior, hands-on IC with strategic oversight