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Sr. Director, Clinical Supply Chain

South San Francisco, California

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   

These values are the foundation of our work, empowering us to make a real difference, every day.  

 

Job Overview

Kardigan is seeking a Sr. Director, Clinical Supply Chain, to support development of a large late phase portfolio. This role will report directly into the VP, Head of External Manufacturing & Supply Chain. 

In this role, you will be responsible for leadership, management and oversight of end-to-end clinical supply chain activities for Kardigan’s portfolio of clinical trials across its cardiovascular pipeline.  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. 

This is a 4-day, onsite position, based in South San Francisco

 

Essential Duties and Responsibilities:

  • Build and lead a high performing, experienced, clinical supply chain group that can successfully support a growing portfolio of both early phase and also multiple complex late phase assets
  • Direct and oversee the end-to-end clinical supply chain, from demand planning to distribution, ensuring on-time, compliant delivery aligned with clinical development plans
  • Collaborate with Clinical development teams to proactively manage supply and demand planning and mitigate risks to the continued advancement of the clinical programs
  • Provide strategic leadership to internal and external teams, ensuring all clinical supply chain activities support broader organizational goals
  • Oversee clinical supply operations, including label generation and approval, packaging and labeling, release, and distribution
  • Manage IRT system implementation, testing, and maintenance
  • Serve as a subject matter expert in clinical supply chain processes, driving innovation and implementing best practices to enhance operational efficiency
  • Author and implement updated processes, Standard Operating Procedures (SOPs), and policies to maintain GMP integrity and harmonized, quality clinical supply chain practices
  • Proactively identify risks to the supply chain and develop risk mitigation strategies
  • Represent Clinical Supply Chain on interdisciplinary project teams (e.g. CMC subteams, trial-specific operations teams, Regulatory, QC/QA etc.)
  • Lead the development of Kardigan’s clinical supply chain team, including overseeing new employee onboarding and providing career development planning and learning opportunities


Qualifications:

  • 10+ years of progressive experience in Clinical Supply Chain, Planning, Manufacturing, or other Supply Chain discipline, preferably in the Biotechnology / Pharmaceutical industry
  • Proven experience selecting and managing label/packaging CMOs
  • Extensive experience setting up and running global clinical trials, including experience working in a variety of IRT systems
  • Demonstrated expertise in clinical supply chain processes, including packaging, labeling, and logistics
  • Extensive knowledge of regulated manufacturing, GMP, GCP and quality systems.  
  • Ability to manage multiple projects in a fast-paced environment.  
  • Strong interpersonal communication skills, proven ability to build and maintain collaborative, effective internal and external relationships. 
  • Excellent written, oral communication, and presentation skills along with the ability to communicate effectively with executive-level management.  
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.    
  • B.A. or B.S. or equivalent, experience in supply chain, shipping and/or logistics. MBA preferred as additional qualification.
  • Supply chain certification is a plus (e.g. APICS, CPIM, CSCP)

 

 

 

 

 

Exact Compensation may vary based on skills, experience and location.

Pay range

$248,000 - $323,000 USD

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