Offre d'emploi : Clinical Supply Chain Manager - Belgium & USA (M/F)

Recruteur
PaHRtners
Région
Gosselies, Charleroi (BE)
Publication
jeudi 16 septembre 2021
Date limite
vendredi 29 octobre 2021
Type de contrat
CDI
Temps de travail
Temps plein

iTeos Therapeutics is a privately-held, clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies.

Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011.

In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO raising over $230million of gross proceeds. In June 2021, iTeos entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, iTeos’s anti-TIGIT monoclonal antibody. As a well-capitalized biotech company, iTeos is positioned to continue to develop our pipeline and maintain investment in our discovery research team to leverage our expertise in tumor immunology to improve the lives of cancer patients.

For more information, please visit www.iteostherapeutics.com.

iTeos Therapeutics is now a world-class biotech in cancer immunotherapy. To carry on its growth, expand its pipeline and reinforce its team, iTeos Therapeutics is looking for a (m/f): Clinical Supply Chain Manager – Belgium & USA.

 

Responsibilities:

As a Clinical Supply Chain Manager (SCM), you will work with project teams, vendors, and CMC to oversee the end-to-end clinical supply chain activity. Your knowledge of the clinical supply chain, GxP regulatory framework and deep understanding of the dynamics and interdependence of both medicinal product and clinical development will be critical for the development of supply strategies to advance iTeos’ clinical pipeline.

The SCM will drive the Global Clinical Supply deliverables and outcomes, as a key point of contact to stakeholders across Clinical, Clinical Operations, CMC, Discovery, Quality Assurance and Regulatory Affairs to advance the development of the ON portfolio. You will be expected to translate early and late-stage product strategies into a supply strategy which balances the needs of partnering organizations while ensuring supply continuity and a patient-centered focus. As the supply chain point of contact, you will provide broad consult on all aspects of clinical supply and be a key decision maker for the development of drug supply and sourcing strategies.

Some key areas of management and strategies are: vendor oversight and forecasting, packaging, labeling, distribution, oversight of inventory management, financial planning/ budgeting of supply needs, and TMF filing of Clinical Supply documents.

The SCM will oversee vendors engaged by iTeos to ensure the following is completed in timelines and budget as contracted:  discussion, Packaging, Distribution, labeling , and IRT Management.  The goal of these interactions is to meet the ever evolving and demanding needs of clinical trials. Through a solid understanding of clinical study design and drug supply risks, the SCM will lead the supply strategies that balance cost and risk without sacrificing patient safety.

This is a highly collaborative role with significant exposure across the pharmaceutical and clinical development spectrums. A successful Supply Chain Manager will utilize their skills in leadership, influence, negotiation, strategic planning, and project management to thrive in a matrixed environment, with the goal of delivering the highest quality clinical supply plans that are patient-focused, risk-adjusted and cost effective for the overall advancement of iTeos’ oncology portfolio. The SCM will be expected to perform an assessment on current processes, identify, recommend, and implement strategies on systems and make improvements for a growing, dynamic biotech environment.

Key responsibilities:

Operational

  • Lead oversight, coordination and selection of various supply chain vendors and services, and other strategic or continuous improvement goals.
  • Lead cross-functional teams, which include internal and external resources, to coordinate and handle the delivery of clinical supplies for specified assets.
  • Manage oversight of packaging, labeling, and distribution of clinical trial material for global clinical trials.
  • Generate multiple supply/ demand scenarios for Finished Good and or Investigational Medicinal Product (final labeled kits). Implement scenarios using appropriate analytical techniques, reporting capability/turning data into information.
  • Use knowledge of tools to increase productivity, manage complexity, and improve forecast quality.
  • Accountable for problem-solving and resolution of issues involving a range of technical, quality, regulatory and operational issues to ensure delivery to patient without compromising quality or cost.
  • Create Study Specific Technical Agreements (or equivalent) for specified projects.
  • Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material.
  • Directly responsible for  all information regarding the global use of investigational material in clinical studies: Forecasting, Packaging, Distribution, Inventory Management, Project Management and Financial Planning/Budgeting

Strategic / Collaborative

  • Working as a key member of the Clinical and Project team, proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives.
  • Translate strategic objectives into plans for team execution.
  •  Influence overall objectives of supply chain planning, forecasting and the clinical programs.
  • Build and maintain strong working relationships with Clinical, cross-functional program teams and vendors, including serving as the first point of escalation for issues related to clinical supply.

Organizational

  • Manage/support cross-functional projects such as cross-functional process/system integration.
  • Responsible to identify opportunities to improve efficiencies and commitment to continuous quality improvement ..

Profile:

  • B.S. or graduate, degree within a scientific discipline required with 8-10 years’ experience in Pharmaceutical or Biotechnology Industry, with at least 5 years in direct Supply Chain Management experience preferred.
  • Experience leading multi-disciplinary teams utilizing project management, negotiation, and strategic planning skillset.
  • Foundational understanding of end-to-end clinical supply chain activities.
  • Understanding of GxP concepts and impact to clinical supply.
  • Ability to develop forecasts and supply plans for investigational products incorporating expiry management and accounting for complex regulatory requirements.
  • Experience leveraging tools and systems to help with demand forecasting.
  • Experience with IRT systems and providing stakeholder input for IRT development.
  • Experience making data-driven decisions with the ability to interpret and present data clearly and effectively to partnering stakeholders.
  • Highly detail oriented with ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills.
  • Proficient knowledge of MS Office (Excel, PowerPoint,  Project, etc).
  • Ability to build positive relationships, with both internal and external partners.
  • Effective collaborator who can bring together multiple stakeholders to develop and implement effective supply chain management strategies.
  • Change-Agility needed, a mindset who can thrive in a dynamic, complex, and regulated environment.
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact

Offer:

  • A stimulating position within a high-potential innovative biotech company
  • The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment
  • A challenging scientific and business growth in which you get to bring your knowledge and skills
  • A permanent contract with an attractive salary package in line with the position responsibilities and your experience

Interested? 

Send your CV together with an adapted cover letter via https://www.pahrtners.be/en/jobs/supply-chain-manager-belgium-usa-en/ or to the following address: recruitment@pahrtners.be

Your application and related information will remain strictly confidential.