Associate Director, Clinical Drug Supply, Clinical

Il y a 2 mois

MontSaintGuibert, Belgique Lilly Temps plein

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Purpose**:
The Clinical Drug Supply (CDS) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the Clinical Design, Delivery & Analytics (CDDA) and Product Research & Development (PRD) to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.

The role of the Clinical Trial Commercial Product, Buyer Planner (CPBP) is to ensure a robust strategy and integrated plan for supplying Commercial Products that supports Lilly Clinical Trials, externally sponsored research, Expanded Access Programs, and decentralized and clinical material trial regulations. The CPBP will use their global expertise for commercial products (procurement, wholesalers, supply chain, etc.) in developing strategies for supplying commercial products to support clinical trials. The CPBP is accountable for development of the Materials Master Requirements Plan, purchasing decisions, and management of Product Delivery (PD) material flow to meet required timelines. Moreover, the CPBP will use their supply chain expertise to influence demand forecasts and leverage innovate sourcing strategies.

This role is critical in delivering the Lilly portfolio and key development milestones. The CPBP will anticipate and resolve technical issues with the supply chain and drive for solutions that meet the needs of the business. The CPBP will collaborate with Supply Planning to ensure the commercial product strategy meets the demands of the molecule/study plan as well as partners with the Commercial Product Material Coordinator to ensure execution of the strategy.

**Key Responsibilities**
- Participate in demand planning and sourcing strategy decisions considering regulatory requirements at a study and asset level through partnership with Supply Planning, Quality and Clinical.
- Have supply chain planning responsibility for Commercial Products, Lilly and Non-Lilly, to meet the demand plan supporting Lilly’s clinical trials and externally sponsored research.
- Work closely with Clinical Trial Supply Managers to understand trial operating model and any constraints/issues with the demand forecast that have implications for the supply plan.
- Initiate, establish, and maintain effective relationships with Lilly commercial and distribution sites, functional areas, and external partners
- Manage business planning, forecast development and tracking spend variances for supported Business Units. This includes supplying the annual and quarterly forecast updates.
- Determine and execute planning heuristics in SAP/APO through Clinical Demand & Operations Planning process, review alerts and plan adjustments
- Optimize plan across the supply chain to ensure demand and minimum dating requirements for finished goods and locally sourced orders can be met or exceeded
- Effectively lead and communicate with the cross-functional Supply Planning and CT Material Operations team to delivery plan, foster an environment of integrated teamwork and collaboration, and influence without authority
- Develop and oversee execution of contingency plans across functions when supply issues arise
- Communication of team performance and wholesaler performance metrics relative to goals. Leverages relationships with key internal Product Delivery (PD partners and other business partners to influence a robust material supply chain (e.g., Quality, Manufacturing, Packaging, and Supply Planning)
- Leverage established relationships with external suppliers (e.g., wholesalers, pharma companies) to influence delivery lead times, cost savings and improving performance metrics)
- Coaches Commercial Product Material Coordinators
- Drives improvement, searching for opportunities to improve productivity, efficiency, compliance, and data accuracy while minimizing costs.
- Develop supply strategies that meet the needs of the business by using data, expertise, and key relationships
- Maintain expertise on clinical trial materials MRP processes, joint Lilly/ Collaboration Partner processes as well, as how those processes connect to PD and Lilly business processes.
- Partnering with Product Delivery, Clinical, Regulatory,

  • Manager Clinical Trial Packaging Material

    il y a 5 jours

    Mont-Saint-Guibert, Belgique Lilly Temps plein

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Trial Assistant

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Novadip Biosciences Temps plein

    **Your responsibilities**: - Primary Role_ Trial Master File management and administrative support, in compliance with SOPs, ICH guidelines (including GCP) and all other EU/US legislations and directives relating to clinical research activities. - Nature and scope of responsibilities_ 1.Trial Master File (TMF) management from study start-up to close-out,...

  • Manager-clinical Trial Distribution Material

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Lilly Temps plein

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Assistant

    Il y a 8 mois

    Mont-Saint-Guibert, Belgique Novadip Biosciences Temps plein

    **Your responsibilities**: - Assist with the management (check, approval, distribution) of specifications, work instructions and other Novadip quality system documents - In collaboration with QC and the QP, assist with the management of the storage facilities for raw materials, intermediates, finished products and packaging materials - Manage the release of...

  • Project Manager

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Panda International Temps plein

    **Project manager**: **Location** - mont saint guibert, Belgium **Business Sector** - Biotechnology **Job ref** - 22774 **Published** - 2 minutes ago **Title: Project Manager**: **Location**: Wallonia, Belgium We are looking for a seasoned Project Manager (5-6 years of experience) with a proven track record in managing complex projects. You are...

  • Head of Regulatory Affairs

    Il y a 3 mois

    Mont-Saint-Guibert, Belgique Novadip Biosciences Temps plein

    **1. Mission**: The Head of Regulatory Affairs is a key member of the Senior Executive Team. As such, he/she provides regulatory strategy to the Chief Executive Officer and takes strategic and operational responsibility for leading global regulatory affairs matters relating to company objectives and programs. As a member of the Senior Executive Team, he/she...

  • Sr. Finance Director

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Cellistic Temps plein

    The mission of Cellistic/ Ncardia is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this mission,...

  • Head of Regulatory Affairs

    il y a 3 semaines

    Mont-Saint-Guibert, Belgique Novadip Biosciences Temps plein

    1. Mission The Head of Regulatory Affairs is a key member of the Senior Executive Team. As such, he/she provides regulatory strategy to the Chief Executive Officer and takes strategic and operational responsibility for leading global regulatory affairs matters relating to company objectives and programs. As a member of the Senior Executive Team, he/she...

  • Marketing Manager

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Clinigen Temps plein

    We’re looking for a Marketing Manager based in Belgium to work on a remote hybrid basis. This position is responsible for designing and implementing marketing and communication initiatives to support the Clinical Services business, as well as other business units and Group-wide projects, as needed. Acting as a Marketing Business Partner, the role aims to...

  • Training and Education Manager

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Guided Solutions Temps plein

    Our client is a fast-growing medical technology company focused on the development and commercialization of innovative solutions and services for the treatment of Obstructive Sleep Apnea (OSA). With this method, patients who are not allowed to undergo conventional treatment receive a significant reduction in apnea and hypopnea events. As part of their...

  • Junior Medical Writer

    il y a 5 jours

    1060 Saint-Gilles, Belgique Oxford Global Resources Temps plein

    Are you a Junior Medical Writer with experience in writing clinical documents and/or publications and are you interested to gain more expertise in one of the biggest pharma companies? Don't hesitate and apply today ! Job Description As a Medical Writer, you will be working on the writing of scientific tender dossiers for which you will be working in...

  • Validation Lead

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Cellistic Temps plein

    The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology, and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to get better, more efficient treatments to patients faster. To achieve this...

  • Production Technician

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Cellistic Temps plein

    Within our Cell Therapy team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Production Technician. **Responsibilities & Duties**: - Works daily in a cleanroom manufacturing environment (Grade A/B/C/D) - Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP...

  • Freelance Medical Writer

    il y a 5 jours

    1060 Saint-Gilles, Belgique Oxford Global Resources Temps plein

    Are you a Junior Medical Writer with experience in writing clinical documents and/or publications and are you interested to gain more expertise in one of the biggest pharma companies? Job Description As a Medical Writer, you will be working on the writing of scientific tender dossiers for which you will be working in tandem with a Tender manager....

  • Logistics Manager

    il y a 3 semaines

    1060 Saint-Gilles, Belgique Dixon Supply Chain Temps plein

    We zijn momenteel op zoek naar een ambitieus, strategisch en gedreven persoon om als logistics manager aan de slag te gaan in regio Brussel. Heb je reeds een mooi traject binnen logistiek/supply chain/customer service achter de rug? Hebben contract management en het voeren van zware onderhandelingen geen geheimen meer voor jou? Ben je goed in change...

  • Logistics Manager

    il y a 4 semaines

    1060 Saint-Gilles, Belgique Dixon Supply Chain Temps plein

    We zijn momenteel op zoek naar een ambitieus, strategisch en gedreven persoon om als logistics manager aan de slag te gaan in regio Brussel. Heb je reeds een mooi traject binnen logistiek/supply chain/customer service achter de rug? Hebben contract management en het voeren van zware onderhandelingen geen geheimen meer voor jou? Ben je goed in change...

  • Logistics Manager/senior Manager

    il y a 3 semaines

    1060 Saint-Gilles, Belgique Dixon Supply Chain Temps plein

    We zijn momenteel op zoek naar een ambitieus, strategisch en gedreven persoon om als logistics manager aan de slag te gaan in regio Brussel. Heb je reeds een mooi traject binnen logistiek/supply chain/customer service achter de rug? Hebben contract management en het voeren van zware onderhandelingen geen geheimen meer voor jou? Ben je goed in change...

  • Logistics Manager

    il y a 3 semaines

    1060 Saint-Gilles, Belgique Dixon Supply Chain Temps plein

    We zijn momenteel op zoek naar een ambitieus, strategisch en gedreven persoon om als logistics manager aan de slag te gaan in regio Brussel. Heb je reeds een mooi traject binnen logistiek/supply chain/customer service achter de rug? Hebben contract management en het voeren van zware onderhandelingen geen geheimen meer voor jou? Ben je goed in change...

  • Analytical Development Scientist

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Cellistic Temps plein

    Within our Cell Therapy team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Production Technician. ***: **The position**: As a Scientist in Analytical Development, your key responsibilities will be to drive development, optimization, and qualification of new analytical methods and equipment associated with hiPSC-based...

  • Sr. Finance Manager

    Il y a 6 mois

    Mont-Saint-Guibert, Belgique Cellistic Temps plein

    The mission of Cellistic/ Ncardia is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this mission,...