Job Description

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 Kardigans mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.

Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigans co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.

We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.

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. 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 67 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

• 67 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)
• Knowledge of GMP, GCP, and quality systems.
• Strong project management and communication skills.
• Bachelors 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.

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Full time, Contract work, For contractors, For subcontractor, Work at office, Visa sponsorship,

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