This role is no longer accepting applications via Rocketlist.
Associate Director, Clinical Supply Chain Management
Korro BioRNA editing company
Cambridge, United StatesDirector
Venrock Healthcare Capital Partners
ADAR1 Capital Management
Affinity Asset Advisors
Balyasny Asset Management
Driehaus Capital Management
Kalehua Capital
Operations & Strategy
About the role
TL;DR
Lead strategic and operational management of clinical supply activities for life-changing therapeutics.
- •The position will lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients.
- •Key Responsibilities Develop and implement end to end supply chain strategies from raw material to finished goods, aligned with corporate and clinical development goals.
- •Work closely with clinical operations/development to develop clinical forecasts/demand plans based on clinical trial requirements, while optimizing supply chain operations to ensure timely availability of investigational medicinal product (IMP)/clinical trial material (CTM).
- •Manage labeling, packaging, distribution, and returns of IMP/CTM with external vendors in compliance with GMP and global regulations.
- •Ensure on time delivery of clinical supplies to depots and clinical sites globally, in compliance with clinical protocol and country specific regulations/requirements.
- •Collaborate with Quality Assurance & Regulatory on activities associated with labelling, packaging, specifications generation, and vendor qualification & audits.
- •Requirements Bachelor’s or advanced degree with a minimum of 10 years of relevant pharmaceutical/biotech experience in supply chain management and operations.
- •Experience in managing activities for global clinical trial supply, including but not limited to labeling, packaging, distribution, and IRT/IXRS inventory management in compliance with GMP and global regulations.
- •External vendor selection and management experience.
- •Experience with global supply chain, material movement, cold chain distribution, and logistics.
- •Experience with trade compliance and import/exports/customs requirements is a strong plus.
- •Excellent written & verbal communication with ability to work independently with minimal oversight.
Required skills
Vendor ManagementCompliance ManagementProject Management
Nice-to-have skills
Risk Management
Domain expertise
biotech