Associate Director, Clinical Supply Chain Management

Position Summary:

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.

Key Responsibilities:

Supply Chain Planning:

• 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.

Clinical Supply Management:

• 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).



Logistics & Distribution Management:

• 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.

 

Quality Assurance and Regulatory Compliance:

• 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.

Required Qualifications:

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