Senior Manager, Clinical Supply Chain Management
4 weeks ago
About us:
Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.
Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.
Position Overview:
The Senior Manager, Clinical Trials Supply Chain will be responsible for managing clinical drug product supply in support of multiple clinical studies across all phases of development. As a member of the Development team, this role will report to our Head of CMC.
Key Duties and Responsibilities:
- Manage investigational drug substance and drug product supplies in support of the clinical development pipeline.
- Ensure on-time delivery of study drug to patients/subjects and management of the clinical supply chain (packaging, labeling, distribution, inventory management, returns, and destruction of IMP/CTM)
- Work collaboratively with Clinical Operations, Clinical Development, Quality, Regulatory, and with external vendors (packaging, IRT)
- Work with cross-functional teams to define the clinical supply plan for each study; and participate in relevant team meetings providing clinical supply status reports and support
- Review clinical protocols for study supply requirements
- Review and approve label text in compliance with regulations, and manage translations and country specific requirements
- Contribute to the design of study drug packaging in accordance with needs of the study
- Manage vendors to perform the labeling, packaging, and global distribution of investigational product
- Develop requirements/specifications for clinical study drug and other drug supply as required (non-GMP and GMP), including inventory, retest dating, packaged product specifications, product shipping and storage specifications
- Contribute to study specific pharmacy manuals and supply related training/instructional materials (e.g. IM and SIV slides, dosing cards, accountability forms)
- Stay current on all Ventus SOP’s related to CTM/IMP distribution and follow procedures for release of IMP to clinical site(s)
- Contribute to annual budget and forecasting; track and approve invoices to contracts
- Provide Regulatory Affairs with applicable information and/or sections of IND/IMPD/CTA/etc. submissions
Requirements:
- Minimum of 6 to 8 years of relevant experience in the pharmaceutical, biotechnology or related industry, and BS/BA preferred
- Knowledge of regulatory requirements for IMP
- External vendor management experience required
- 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 (approximately 10% of time)
- This position can be remote, although proximity to one of our sites (Waltham, MA or Montreal, Quebec) is preferred
___________________________________________________________
A propos de nous :
Ventus Therapeutics est une société biopharmaceutique au stade clinique qui déploie des outils de pointe en biologie structurale et en chimie computationnelle pour créer de nouveaux médicaments à petites molécules destinés à des cibles difficiles en immunologie, en inflammation et en neurologie.
Notre plateforme propriétaire de découverte de médicaments, ReSOLVETM, nous permet de découvrir et de développer des médicaments grâce à des connaissances uniques sur les cibles protéiques et de créer des schémas dynamiques qui peuvent guider le développement de thérapies différenciées à un rythme rapide. Nous souhaitons utiliser la plateforme ReSOLVE pour améliorer la façon dont les médicaments sont découverts et développés, dans le but ultime de rétablir la santé des personnes atteintes de maladies graves.
Aperçu du poste :
Le Senior Manager, Clinical Trials Supply Chain, sera responsable de la gestion de l'approvisionnement en produits pharmaceutiques cliniques à l'appui de plusieurs études cliniques à toutes les phases du développement. En tant que membre de l'équipe de développement, ce poste est placé sous la responsabilité de notre chef de service CMC
Principales tâches et responsabilités :
- Gérer les approvisionnements en substances médicamenteuses expérimentales et en produits pharmaceutiques à l'appui du pipeline de développement clinique.
- Assurer la livraison en temps voulu des médicaments de l'étude aux patients/sujets et la gestion de la chaîne d'approvisionnement clinique (conditionnement, étiquetage, distribution, gestion des stocks, retours et destruction des IMP/CTM).
- Travailler en collaboration avec les opérations cliniques, le développement clinique, la qualité, la réglementation et les fournisseurs externes (emballage, IRT).
- Travailler avec des équipes interfonctionnelles pour définir le plan d'approvisionnement clinique pour chaque étude et participer aux réunions d'équipe pertinentes en fournissant des rapports sur l'état de l'approvisionnement clinique et en apportant son soutien.
- Examiner les protocoles cliniques pour déterminer les besoins en fournitures de l'étude
- Examiner et approuver le texte de l'étiquette conformément à la réglementation, et gérer les traductions et les exigences spécifiques à chaque pays.
- Contribuer à la conception de l'emballage des médicaments de l'étude conformément aux besoins de l'étude.
- Gérer les fournisseurs chargés de l'étiquetage, de l'emballage et de la distribution mondiale des produits expérimentaux.
- Élaborer des exigences/spécifications pour les médicaments destinés aux études cliniques et autres médicaments, selon les besoins (hors BPF et BPF), y compris l'inventaire, la datation des contre-essais, les spécifications des produits emballés, l'expédition des produits et les spécifications de stockage.
- Contribuer à l'élaboration de manuels pharmaceutiques spécifiques à l'étude et fournir du matériel de formation et d'instruction (par exemple, diapositives IM et SIV, cartes de dosage, formulaires de responsabilité).
- Se tenir au courant de toutes les SOP de Ventus relatives à la distribution de CTM/IMP et suivre les procédures de distribution des IMP au(x) site(s) clinique(s).
- Contribuer au budget annuel et aux prévisions ; suivre et approuver les factures des contrats.
- Fournir aux affaires réglementaires les informations et/ou les sections applicables des soumissions IND/IMPD/CTA/etc.
Exigences :
- Minimum de 6 à 8 ans d'expérience pertinente dans l'industrie pharmaceutique, biotechnologique ou connexe, et BS/BA de préférence.
- Connaissance des exigences réglementaires pour la PMI
- Expérience de la gestion des fournisseurs externes requise
- Capacité à travailler de manière indépendante avec un minimum de supervision
- Solides compétences interpersonnelles et capacité à travailler dans un environnement d'équipe dynamique.
- Solides compétences informatiques, avec maîtrise des tableurs, des logiciels de présentation et de traitement de texte.
- Flexibilité pour voyager dans le cadre des activités de l'entreprise (environ 10 % du temps)
- Ce poste peut être occupé à distance, mais la proximité de l'un de nos sites (Waltham, MA ou Montréal, Québec) est préférable.
-
Senior Manager, Clinical Supply Chain Management
4 weeks ago
Montréal, QC, Canada Ventus Therapeutics Full timeAbout us: Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and...
-
Senior Manager, Clinical Supply Chain Management
4 weeks ago
Montréal, QC, Canada Ventus Therapeutics Full timeAbout us: Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and...
-
Operations Manager
3 weeks ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment, and enables our team to thrive. Managing 14...
-
montréal, Canada Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and develop...
-
supply chain Analyst
1 day ago
Longueuil, QC, Canada Fed Supply Full timeHello ! I'm Anissa, Recruitment Consultant for Fed Supply, an employment agency specializing in supply chain, logistics, transportation and customer service - offering temporary and permanent jobs in the Greater Montreal area. Our team, experts in Supply Chain and Logistics, speaks your language and evolves in your world Bonjour ! Je suis Anissa,...
-
Supply Chain Manager
2 weeks ago
Montréal, Canada Foodtastic Full time**About the Company** Founded in 2016, Foodtastic is already one of the largest restaurant companies in Canada. We have increased system sales in the last four years from less than $50mm to over $750mm. Our current portfolio of 23 brands includes Milestones Grill & Bar, Second Cup Café, Pita Pit, La Belle et La Boeuf, and Rôtisseries Benny. **Supply...
-
Supply Chain and Logistics Analyst
1 day ago
Montréal, QC, Canada Fed Supply Full timeI'm Anissa, Recruitment Consultant for Fed Supply, an employment agency specializing in supply chain, logistics, transportation and customer service - offering temporary and permanent jobs in the Greater Montreal area. Our team, experts in Supply Chain and Logistics, speaks your language and evolves in your world. Je suis Anissa, Conseillère en...
-
Team Lead
4 weeks ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment, and enables our team to thrive. Managing 14...
-
Operations Supervisor
3 weeks ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment, and enables our team to thrive. Managing 14...
-
Montréal, QC, Canada Fed Supply Full timeHello ! I'm Anissa, Recruitment Consultant for Fed Supply, an employment agency specializing in supply chain, logistics, transportation and customer service - offering temporary and permanent jobs in the Greater Montreal area. Our team, experts in Supply Chain and Logistics, speaks your language and evolves in your world. Bonjour ! Je suis Anissa,...
-
Supply Chain Analyst
1 day ago
Longueuil, QC, Canada Fed Supply Full timeI'm Anissa, Recruitment Consultant for Fed Supply, an employment agency specializing in supply chain, logistics, transportation and customer service - offering temporary and permanent jobs in the Greater Montreal area. Our team, experts in Supply Chain and Logistics, speaks your language and evolves in your world Je suis Anissa, Conseillère en recrutement...
-
Inventory Control Coordinator
4 weeks ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment, and enables our team to thrive. Managing 14...
-
Reverse Coordinator
1 week ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain (MTH) is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment, and enables our team to thrive. Managing 14...
-
Forklift Operator
2 weeks ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment, and enables our team to thrive. Managing 14...
-
Warehouse Team Member
3 weeks ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain (MTH) is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment, and enables our team to thrive. Managing 14...
-
Operations Support Coordinator
2 weeks ago
Montréal, Canada Metro Supply Chain Full timeJOIN OUR TEAM Metro Supply Chain is a strategic supply chain solutions partner for some of the world’s fastest growing and most recognizable organizations. We advance our customers’ business through innovative, real-world solutions within a culture that supports our communities, protects our environment and enables our team to thrive. Over the past 40+...
-
Site Manager Supply Chain
3 weeks ago
Montréal, QC, Canada Maxi Full timeCome make your difference in communities across Canada, where authenticity, trust and making connections is valued - as we shape the future of Canadian retail, together. Our unique position as one of the country's largest employers, coupled with our commitment to positively impact the lives of all Canadians, provides our colleagues a range of opportunities...
-
Supply Chain Manager
2 weeks ago
Montréal, Canada Galvion Full time**THE COMPANY** At Galvion, we are passionately committed to providing leading-edge solutions and equipment that enhance the overall agility and survivability of the modern warfighter. We design, develop, and deliver protective armor and head systems, as well as innovative power supply and management solutions for military and tactical operators...
-
Supply Chain Manager
2 weeks ago
Montréal, Canada Galvion Full time**THE COMPANY** **THE OPPORTUNITY** A unique opportunity exists for an experienced Supply Chain Manager to join our team to oversee all Supply Chain activities for Galvion's Armor Business Unit, primarily at our Newport, VT location. The Supply Chain Manager must be based in/near Montreal, QC. You will be required to be in the Newport, VT facility 3 days...
-
Supply Chain Manager
3 weeks ago
Montréal, Canada Galvion Full time**THE COMPANY** Galvion designs, develops, and manufactures ballistic helmets and dynamic power and data management solutions for the modern battlefield. We are a passionate, global, and fast-paced team working with several strategic partners and are committed to enhancing the overall agility and survivability of the modern warfighter and tactical...