Manager, Clinical Supply Chain

We want to solve immune dysfunction.

Many cancers and other diseases are caused, or resist treatment, because T cells can't recognize or target cells correctly. We're progressing first-in-class antigen modulators through the clinic, developed to treat disease by controlling T cell activation. Our technology modulates antigen presentation, flicking a switch inside cells to alter their appearance to the immune system.

This approach marks a fundamental shift in how we treat people living with autoimmune disorders, cancers and infectious diseases.

Role Overview

Due to ongoing growth, we are recruiting a new Clinical Supply Manager role to join the CMC team. This position is ideal for an enthusiastic, result-driven professional who thrives at the cross-functional interface between CMC, clinical supply management and Clinical Operations.

You will be coordinating the planning, management and supply of IMP for all Greywolf’s global clinical trials.

Core Responsibilities

• Managing all activities related to Clinical Supply Management including batch packaging, labelling, distribution strategy, expiry updates and label translations delivering IMP on time and right first time.
• In collaboration with Head of CMC, own the clinical supply forecasting based on the clinical study design and any subsequent evolution of the clinical protocol through amendments.
• Coordinating activities between internal stakeholders (Head of CMC, CMC Project Manager, GMP QA, Clinical Operations leads and Asset level Project Managers) and relevant CDMO partners to ensure timely delivery of the required clinical supplies.
• Represent the CMC team at asset-specific Clinical Study Team (CST) and communicate effectively on project progress.
• Partner with Clinical Operations Leads, Head of CMC and CMC Project Manager to understand clinical demand requirements and ensure alignment with study teams on clinical supply plans and timelines including the ability to interpret and advise on protocol design with respect to supplies.
• Liaise with Clinical Operations Leads on site initiation and patient visit timings and ensure IMP is provided in a timely manner. While having an understanding of the IMP and Subject Matter Expert on Pharmacy activities and dosing aspects of the IMP.
• Author Investigational Product Handling and Pharmacy Manuals, providing key drug supply and ancillary handling information.
• Subject matter expert for the IRT (Interactive Response Technology) drug supply and reconciliation modules. Key member of sponsor team with a strong understanding of patient randomisation and strata and establishing IRT design and User Acceptance Testing supporting clinical teams.
• Manage clinical supply inventory and IMP tracking, develop inventory reports and monitor upcoming expiry across all Greywolf clinical trials through to study close out.
• Drive activities around PLD (packaging, labelling and distribution) including batch record reviews and reconciliation, CDMO and depot selection for the supply chain, contracting and management of out of scope activities
• Coordinate batch release with CDMOs for intermediate release and final release as well as Greywolf QA sponsor release
• Assist in monitoring and tracking product re-test/expiration for clinical supplies including re-labelling activities and country specific product release
• Assist QA/CMC team in the investigation of deviations related to clinical supplies, resolving shipment issues, recommending appropriate corrective and preventative actions
• Providing budget estimates and updates to Head of CMC during budget forecasting.
• Manage and adhere to the supplies budget with PL&D vendors through the lifecycle of the program, communicating changes to the Head of CMC as appropriate
• Manage clinical supply CDMOs in inventory reconciliation and disposition for unlabelled and labelled packaged drug products.
• Ensuring compliance with company internal procedures and GXP requirements by close collaboration with QA and Clinical Operations and approved vendors.

Skills, Knowledge, Qualifications and Experience

• BSc or MSc in a relevant scientific discipline (chemistry, pharmaceutical science).
• Knowledge of global pharmaceutical regulatory requirements (e.g. cGMP, GCP).
• Knowledge of IRT system set-up, functionality and regular use.
• 5+ years of experience in a clinical stage biotech/mid-size pharma or CDMO business (preferably a combination of both).
• Proven track record in clinical supply chain management.
• Understanding of supply chain networks, Quality (GMP/GCP), clinical regulations, timelines and quality to facilitate communications to leadership and to develop efficient clinical supply solutions balancing multiple business objectives.
• Ability to adapt and pivot following changes in the clinical study design including mid-study.
• Ability to work in a fast-paced cross-functional environment.
• Thinking out of the box and pre-empting issues.

If you are passionate about Clinical Supply Chain Management and want to work in a fast growing and exciting company, we invite you to apply and contribute to our mission of advancing ground-breaking discoveries.

What Sets You Apart

• Experience with adaptive clinical trials design.
• Ability to work at the interface of multiple disciplines: CMC, Clinical Supplies and Clinical Operations.

(Some of..) our Perks and Benefits

• 2 holiday office shut-down periods during July and December, in addition to 25 days annual holiday.
• Flexible, hybrid working (you should be able to attend our office in Milton Park, Oxfordshire 1-2 times per week and travel to partner sites, board and other meetings, as required).