Kardigan
Associate Director, Clinical Supply Chain
Kardigan, South San Francisco, California, us, 94083
Overview
Kardigan is seeking an Associate Director, Clinical Supply Chain, to support development of a large late phase portfolio. This role will report directly into the Senior Director, Clinical Supply Chain. Key Responsibilities
Interprets clinical study protocols to determine drug supply forecast and inventory requirements Establishes 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 CMOs for packaging, labeling and distribution activities Partners with other departments to identify, mitigate and resolve compliance and quality issues Represents Clinical Supplies on interdisciplinary project teams (e.g., Tech Ops subteam, Study Execution Teams, Regulatory, QC/QA) Supports QA during audits and inspections related 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
8-9 years of experience in Clinical Supply Chain, Planning, or Manufacturing, preferably in biotech/pharma. Minimum of 6 years of experience with an MBA. Experience with global clinical trials (EU/UK experience required) 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. Exact compensation may vary based on skills, experience and location. Pay range: $178,000 - $232,000 USD Location
4-day onsite position (Monday-Thursday) based in South San Francisco or Princeton, NJ Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is voluntary and will not affect hiring decisions. Any information you provide will be confidential. Kardigan is an equal opportunity employer and does not discriminate on the basis of any protected status. See the policy for details. Disability Status and Disability Disclosure information is available as part of the voluntary self-identification process. Completion is voluntary. PUBLIC BURDEN STATEMENT: This survey should take about 5 minutes to complete. OMB Control Number 1250-0005. Expires 04/30/2026.
#J-18808-Ljbffr
Kardigan is seeking an Associate Director, Clinical Supply Chain, to support development of a large late phase portfolio. This role will report directly into the Senior Director, Clinical Supply Chain. Key Responsibilities
Interprets clinical study protocols to determine drug supply forecast and inventory requirements Establishes 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 CMOs for packaging, labeling and distribution activities Partners with other departments to identify, mitigate and resolve compliance and quality issues Represents Clinical Supplies on interdisciplinary project teams (e.g., Tech Ops subteam, Study Execution Teams, Regulatory, QC/QA) Supports QA during audits and inspections related 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
8-9 years of experience in Clinical Supply Chain, Planning, or Manufacturing, preferably in biotech/pharma. Minimum of 6 years of experience with an MBA. Experience with global clinical trials (EU/UK experience required) 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. Exact compensation may vary based on skills, experience and location. Pay range: $178,000 - $232,000 USD Location
4-day onsite position (Monday-Thursday) based in South San Francisco or Princeton, NJ Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is voluntary and will not affect hiring decisions. Any information you provide will be confidential. Kardigan is an equal opportunity employer and does not discriminate on the basis of any protected status. See the policy for details. Disability Status and Disability Disclosure information is available as part of the voluntary self-identification process. Completion is voluntary. PUBLIC BURDEN STATEMENT: This survey should take about 5 minutes to complete. OMB Control Number 1250-0005. Expires 04/30/2026.
#J-18808-Ljbffr