Associate Director, Clinical Supply Chain Management

Korro Bio•Cambridge, MA

7d•$150,000 - $200,000

About The Position

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. The ideal candidate will bring deep expertise in supply chain strategy and vendor oversight, with a strong understanding of global GMP and regulatory requirements, and ensures uninterrupted, compliant, and cost-effective delivery of investigational products to global clinical trial sites. This role collaborates with Clinical Operations/Development, Quality, Regulatory Affairs, and external partners to manage supply planning, inventory management, and distribution & logistics aligned with GMP and regulatory guidelines. Excellent written and oral communication skills are required, as is the desire and ability to work in a small, fast-paced, and patient-focused environment.

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.
Strong understanding of global regulatory requirements for IMP/CTM.
External vendor selection and management experience.
Experience with global supply chain, material movement, cold chain distribution, and logistics.
Ability to manage multiple projects and to proactively identify risks and implement solutions.
Excellent written & verbal communication with ability to work independently with minimal oversight.
Strong interpersonal skills and ability to function in a dynamic team environment.
Strong computer skills, with proficiency in spreadsheet, presentation, and word processing software.
Flexibility to travel on company business as required.

Nice To Haves

Experience with trade compliance and import/exports/customs requirements is a strong plus.

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).
Establish and manage vendor relationships for outsourced supply chain services. Develop budget and track invoices to contracts.
Manage labeling, packaging, distribution, and returns of IMP/CTM with external vendors in compliance with GMP and global regulations.
Manage creation of label text/translation and design of study drug packaging in compliance with country-specific regulations and study requirements.
Develop Interactive Response Technology (IRT) supply & return strategy, lead/oversee the IRT set up, and participate in User Acceptance Testing (UAT) where needed.
Develop requirements/specifications for clinical study drug and other drug supply as required, including packaged product specifications and product shipping & storage specifications.
Ensure on time delivery of clinical supplies to depots and clinical sites globally, in compliance with clinical protocol and country specific regulations/requirements.
Actively monitor IMP inventory levels at global depots & clinical sites and coordinate resupply to prevent stockouts.
Author study specific pharmacy manuals and supply related training/instructional materials (e.g. IM and SIV slides, dosing cards, accountability forms).
Oversee shipping & handling of temperature-sensitive DS/DP/IMP & related products across different countries/borders, ensuring compliance with cGMP, GDP, and country-specific requirements. Manage temperature excursions and support investigations & CAPA to ensure uninterrupted supply.
Collaborate with manufacturing sites & shipping companies to develop & establish procedures/framework for global material movement and supply chain optimization, with a focus on IOR, trade compliance, HTS codes, duties/VAT, and import/exports/customs requirements.
Collaborate with Quality Assurance & Regulatory on activities associated with labelling, packaging, specifications generation, and vendor qualification & audits.
Support regulatory submissions (IND/IMPD/CTA/etc) and ensure inspection readiness for global regulatory audits.
Establish and maintain clinical supply & distribution SOPs and documentation, supporting compliance and continuous improvement. Stay current on established SOPs and follow procedures for the release of IMP to clinical sites.