Lead Clinical Supply Chain Strategist

2 weeks ago


Greater Philadelphia Area, United States Larimar Therapeutics Full time
Job Title:

Associate Director/Director, Clinical Supply Chain Strategy

About Us:

Larimar Therapeutics is a pioneering biotech firm dedicated to developing innovative treatments for rare diseases using cutting-edge cell penetrating peptide technology. With a strong focus on quality and regulatory compliance, we strive to push the boundaries of clinical supply chain management.

Job Description:

We seek an experienced Clinical Supply Chain Strategist to join our team and lead the planning, organization, direction, and implementation of end-to-end clinical supply chain strategies from study start-up to close-out at contract service providers (CSPs) on behalf of Larimar Therapeutics, Inc.

Key Responsibilities:
  • Develop and implement comprehensive clinical supply chain strategies to support successful clinical trial execution, ensuring seamless collaboration with internal partners and external providers.
  • Analyze clinical protocols to determine drug supply forecasts and inventory requirements, collaborating with relevant stakeholders to create optimized packaging designs.
  • Generate regulatory content to support development phases from FIH trials to BLA filing.
Requirements:
  • Bachelor's degree in supply chain management, logistics, pharmacy, engineering, or a related field; advanced degree (e.g., MBA, MS) or CSCP certification preferred.
  • Minimum 8-10 years of experience in clinical supply chain management within the pharmaceutical or biotechnology industry, with a proven track record of successfully managing complex clinical trials.
  • Significant experience in managing global phase 1 to 4 clinical studies.
  • Proven ability to collaborate effectively with internal partners and external providers, ensuring effective communication and issue resolution.
  • Detailed understanding of Good Manufacturing Practices and Good Distribution Practices requirements, EP regulations, EU GDPs, Annex 13, CFR regulations, and ICH Guidelines governing conduct of clinical studies.
Estimated Salary:

$120,000 - $180,000 per annum, based on experience and qualifications.

Benefits:

Larimar Therapeutics offers a comprehensive benefits package, including incentive stock options, a 401K plan, and flexible PTO policy, as well as opportunities for professional growth and development.


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