Hybrid Sr. Manager, Clinical Supply Chain presso Kardigan

Job Overview

Kardigan is seeking a Sr. Manager, Clinical Supply Chain, to support development of a large late phase portfolio. This role will report directly into the Senior Director, Clinical Supply Chain.

In this role, you will be responsible for managing clinical supply operations across multiple global trials. The ideal candidate will bring 6–7 years of experience in clinical supply chain or related disciplines within the biotech or pharmaceutical industry. Responsibilities include planning of clinical trials’ demand and packaging supply through study execution, IRT management, packaging & label development, label/pack CMO selection & management, distribution & logistics of IMP to clinical sites globally, and study close out. You will ensure that key project deliverables are met according to the budget, timelines and quality standards, as defined by regulations, SOPs, and ICH, with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Kardigan is a 4-day, onsite company (M-Th),

This position can be based in South San Francisco or Princeton NJ

Key Responsibilities

• Interprets clinical study protocols to determine drug supply forecast and inventory requirements
• Establish strategies, supply plans and risk-based timelines for the timely and compliant delivery of IMP to clinical sites
• Manages the packaging, labeling, distribution, returns, reconciliation and destruction of supplies to support global clinical studies at all phases of development
• Monitors global inventory levels and expiry dates to ensure availability of clinical supplies without interruption
• Proactively identifies risks to the supply chain and develops risk mitigation strategies
• Designs, configures, and tests IRT systems for drug supply management, accountability, and randomization of global clinical studies
• Generates labels that comply with global regulatory agencies for investigational new drugs and manages the translation of those labels
• Manages batch record review and batch release of packaging and labeling activities to support multiple clinical studies
• Develops and contributes to internal processes and SOPs for clinical labeling, distribution, returns, reconciliation, and destruction activities for clinical trial materials
• Participates in the selection, evaluation and approval of contract manufacturing organizations (CMOs) for packaging, labeling and distribution activities.
• Partners with other departments to identify, mitigate and subsequently resolve compliance and quality issues
• Represents Clinical Supplies on interdisciplinary project teams (e.g. Tech Ops subteam, Study Execution Teams, Regulatory, QC/QA etc.)
• Supports QA during all audits and inspections, especially those by government agencies, as they pertain to labeling and distribution practices
• Ensures adequate documentation processes and systems are available and followed for labeling, distribution, returns, reconciliation and destruction of clinical trial material activities (SOPs/Protocols review/approval)

Qualifications

• 6–7 years of experience in Clinical Supply Chain, Planning, or Manufacturing, preferably in biotech/pharma. Minimum of 5 years w/ an MBA.
• Experience with global clinical trials (EU/UK Experience Required)
• Extensive IRT experience (Suvoda experience preferred).
• Knowledge of GMP, GCP, and quality systems.
• Strong project management and communication skills.
• Bachelor’s degree required; MBA or supply chain certifications (APICS, CPIM, CSCP) preferred.

About Kardigan

Kardigan is a biopharmaceutical company dedicated to developing innovative treatments for cardiovascular diseases. We foster a collaborative and inclusive culture where employees are empowered to make a meaningful impact.