Korro

Biopharmaceutical

AssociateDirector,ClinicalSupplyChainManagement

$150–200k Cambridge, Massachusetts, United States FULL TIME Remote Friendly
The Brief

“Associate Director, Clinical Supply Chain Management at Korro. Skills: Clinical supply chain, Supply chain strategy, Vendor management, Regulatory compliance. Lead strategic and operational management. Develop and implement supply chain strategies”

What You'll Achieve.

Ensure uninterrupted, compliant, cost-effective delivery; Prevent stockouts

Industry & Context.

Biopharmaceutical
Problems you'll solve

Identify risks; Implement solutions

Eligibility Requirements

Flexibility to travel on company business

What They're Looking For.

Must Have

Bachelor's or advanced degree, 10 years of relevant experience, Global clinical trial supply management, Labeling, packaging, distribution experience, IRT/IXRS inventory management, GMP and global regulations compliance, Global regulatory requirements understanding, External vendor selection and management, Global supply chain experience, Cold chain distribution experience, Logistics experience, Manage multiple projects, Identify risks and implement solutions, Excellent written & verbal communication, Work independently with minimal oversight, Interpersonal skills, Function in a dynamic team environment, Computer skills, Proficiency in spreadsheet software, Proficiency in presentation software, Proficiency in word processing software, Flexibility to travel

Nice to Have

Trade compliance experience, Import/exports/customs requirements experience

What You'll Do.

Lead strategic and operational management

Develop and implement supply chain strategies

Develop clinical forecasts/demand plans

Optimize supply chain operations

Establish and manage vendor relationships

Track invoices to contracts

Manage creation of label text/translation

Manage design of study drug packaging

Develop IRT supply & return strategy

Lead/oversee IRT set up

Participate in User Acceptance Testing

Develop requirements/specifications for clinical study drug

Ensure on time delivery of clinical supplies

Monitor IMP inventory levels

Coordinate resupply to prevent stockouts

Author study specific pharmacy manuals

Author supply related training/instructional materials

Oversee shipping & handling of temperature-sensitive products

Manage temperature excursions

Support investigations & CAPA

Collaborate with manufacturing sites & shipping companies

Develop & establish procedures/framework for global material movement

Collaborate with Quality Assurance & Regulatory

Support regulatory submissions

Ensure inspection readiness for global regulatory audits

Establish and maintain clinical supply & distribution SOPs

Support compliance and continuous improvement

Follow procedures for release of IMP

How You'll Work.

Team & Collaboration

Clinical Operations/Development; Quality; Regulatory Affairs; External partners; Manufacturing sites; Shipping companies; Quality Assurance; Regulatory

Communication Scope

Written communication; Oral communication

Process & Methodology

Manage multiple projects

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