Clinical Supplies Specialist – Clinical & Medical Affairs
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time
Experience: 2–5 Years (Clinical Supply Management / Clinical Trials)
Qualification: Bachelor’s Degree or equivalent
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Clinical Supplies Specialist to oversee clinical supply planning and management across clinical trials.
The role involves managing the end-to-end clinical supply chain including forecasting, packaging, labelling, distribution, and return/destruction of clinical trial materials. The position requires collaboration with cross-functional teams to ensure timely and efficient supply of investigational products.
This role plays a key part in supporting biosimilar clinical development programs while ensuring compliance with global regulatory and quality standards.
Key Responsibilities
Clinical Supply Planning & Strategy
Develop and maintain supply plans for clinical studies.
Integrate enrolment projections, manufacturing timelines, and protocol requirements into supply strategies.
Forecast demand for comparator and reference products.
Support procurement planning for clinical trial materials.
Clinical Supply Operations
Plan and manage clinical supply activities including packaging, labelling, shipment, and returns.
Oversee procurement of reference listed drugs and ancillary supplies.
Manage cold chain logistics and storage requirements.
Ensure timely availability of investigational medicinal products (IMP).
Risk Management & Forecasting
Conduct risk assessments to identify supply constraints.
Develop mitigation strategies to manage supply risks.
Work with study teams to forecast enrolment and drug supply needs.
Monitor inventory levels and supply chain performance.
Vendor & Budget Management
Collaborate with vendors for supply-related activities.
Support Request for Proposals (RFP) and Scope of Work (SOW) processes.
Track vendor performance and ensure compliance with service agreements.
Manage budgets and monitor spending for outsourced services.
Packaging, Labelling & Distribution
Design packaging and labelling strategies for clinical supplies.
Drive label creation, approval, and translation processes.
Ensure compliance with country-specific regulatory requirements.
Develop IMP distribution and return plans.
Documentation & Compliance
Maintain supply documentation, audit trails, and inventory records in systems such as IRT, ERP, and eTMF.
Ensure compliance with GMP, GCP, and global regulatory standards.
Support regulatory inspections as a subject matter expert.
Develop and update SOPs, policies, and work instructions.
Cross-Functional Collaboration
Collaborate with Clinical Operations, Regulatory Affairs, and Project Management teams.
Support clinical trial execution through effective supply coordination.
Align with CROs and supply vendors to ensure project delivery.
Required Skills
Clinical Supply Chain Expertise
Experience in clinical supply management across clinical trials.
Understanding of biologics or biosimilar supply chains.
Knowledge of cold chain logistics and drug handling.
Technical & Systems Knowledge
Experience with IRT systems and supply forecasting tools.
Familiarity with ERP and eTMF systems.
Ability to manage inventory and supply documentation.
Regulatory & Compliance Knowledge
Understanding of GxP, GMP, and GCP requirements.
Knowledge of regulatory guidelines from EMA and FDA.
Experience ensuring compliance in clinical supply operations.
Communication & Collaboration
Strong interpersonal and communication skills.
Ability to work independently and within cross-functional teams.
Strong organizational and problem-solving abilities.
Preferred Qualifications
Experience in biosimilar clinical development programs.
Experience working with CROs and global clinical supply vendors.
Knowledge of clinical trial supply chain best practices.
Key Competencies
Clinical supply planning and forecasting
Clinical trial supply chain management
Regulatory compliance (GMP, GCP, GxP)
Vendor and budget management
Risk assessment and mitigation
Cross-functional collaboration
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines.
The company’s Integrated Clinical and Medical Research (iCMR) department within R&D supports clinical development strategies aligned with global regulatory requirements and biosimilar guidelines, enabling successful clinical trials and post-marketing activities.
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