Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management.
Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates.
The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For ourClinical Supplies function, within the Pharmaceutical Development department, we are looking for a :
Head of Clinical Trial Supply
In this role, the incumbent will lead the Clinical Trial Supply function (4 Clinical Trial Supply Managers and one documentation associate).
The role also includes operational clinical trial supply activities for clinical studies of Debiopharm portfolio.
This role reports to the Associate Director CMC Regulatory Documentation & Clinical Supplies.
Your main responsibilities :
As Manager, you will :
Be responsible for resource planning within the Clinical Supply team across a diverse range of studies (Phase I to Phase III, including Investigator sponsored trials, compassionate use and expanded access)
Manage team members, and when needed act as the subject-matter expert in Clinical Supply to support team in case of questions and / or particular challenges.
Promote team exchanges and learning.
Work on process optimization and promote change within Clinical Supply and also with the other functions to achieve higher efficiency.
Develop and implement team strategy in terms of ways of working, tools and standard operating procedures, budget, management in partnership with key internal stakeholders (Quality, CMC, clinical operations, regulatory, etc).
Establish and lead collaboration with external partners (vendor management for CTS, SOC and comparator sourcing, etc).
Promote collaboration : be the liaison with the other functions (collect inputs or escalate challenges in a solution-oriented manner).
In addition, you will also have operational activities for assigned studies :
Based on protocol outlines, evaluate the feasibility and build a proposal for the supply of clinical trials in terms of packaging design, quality and regulatory compliance and supply chain.
Manage the Contract Manufacturing Organization (CMO) performing the operational activities from packaging design to on site delivery, return, reconciliation and destruction.
Collaborate to the IMP needs estimate and define a supply strategy with the CMC Project Leader and the Clinical Trial Manager (CTM).
Set-up the packaging, labelling, storage and management of IMP with the internal (data management, CTM,...) and external stakeholders (Contract Research Organization (CRO), CMO, Interactive Response Technology (IRT) vendors).
Coordinate the sponsor and Qualified Person release of IMP in collaboration with both internal and external (CMO) Quality Management, as well as Regulatory Affairs.
Ensure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines
Your profile :
Min. 10 years of experience in Clinical Trial Supplies management for phase I to phase III international clinical studies (double-blind, comparator and standard of care sourcing), combined with min.
2 years of people management.
Proven track record of leadership experience in Clinical Supply.
Previous experience in process optimization and vendor management
Broad understanding and experience in setting up (specification definition) of the main tools related to IMP management (simulation tools, IRT / Interactive Web Response System, )
Broad understanding of regulatory and Good Manufacturing Practices requirements for IMP supply.
Project management skills, expertise of outsourcing
Excellent communication skills
Strong ability to work cross-functionally
English fluent is a must, French is an asset