Associate Director/Director, Clinical Supply Chain Strategy

5 days ago

BalaCynwyd, United States Larimar Therapeutics Full time
Job DescriptionJob Description
Description:

The Company:

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.


Position:

Associate Director/Director of Clinical Supply Chain Strategy and Operations


Position Summary:

Reporting with the CMC Technical Operations Team, the Associate Director/Director of Clinical Supply Chain Strategy and Operations plans, organizes, directs, and implements end-to-end clinical supply chain strategies to support the successful execution of clinical trials from study start-up to close-out at contract service providers (CSPs) on behalf of Larimar Therapeutics, Inc. This position works cross functionally within and across departments (Clinical Operations, Drug Substance Manufacturing, and Drug Product Manufacturing) to achieve objectives and is responsible for managing, supporting, and providing direction and leadership to project teams and functional leaders. In addition, the Associate Director/Director of Clinical Supply Chain Strategy and Operations will take a hands-on approach to help functional leaders address critical supply strategies across the Larimar network.


Job Responsibilities:


The responsibilities may include but are not limited to the following activities:


Strategic:

  • Develop and implement end-to-end clinical supply chain strategies to support the successful execution of clinical trials, from study start-up to close-out.
  • Interpret clinical protocols to determine drug supply forecast and inventory requirements. Collaborate with relevant partners to create a packaging design based on clinical study needs to ensure an optimized supply plan.
  • Generation of regulatory content to support all phases of development from FIH trials to BLA filing.

Packaging, Labeling and Distribution:

  • Oversee packaging, labeling, and distribution activities for investigational drugs, ensuring compliance with quality and regulatory requirements and industry standards. This includes requesting and reviewing proposals, communications of project requirements, and management of project execution.
  • Manage the development of study specific labels that comply with SOPs and applicable regulations.
  • Responsible for the labeling, distribution, returns, reconciliation, and destruction of supplies to support global clinical studies at all phases of development for rare diseases
  • Manage batch record review and release of packaging/labeling activities of clinical supplies
  • Manage and optimize inventory levels of investigational drugs across multiple clinical trials at clinical trial sites and depots, accounting for study requirements, patient enrollment projections, and site demand forecasts.
  • Procurement and management of study drug, ancillary supplies, co-drugs/comparators, and medical devices/equipment.
  • Manage internal and third-party deviations, customer complaints, and change controls

Clinical Study Execution:

  • Develop and maintain IB's, pharmacy manuals, and IFU's in collaboration with clinical operations and clinical development.
  • Participate in the selection, design, configuration, review, and User Acceptance Testing of IRT systems for drug supply management, accountability, and randomization of global clinical studies
  • Ensure all study related GMP documents are accurate and filed in a timely fashion in the TMF as per the Good Manufacturing Practices and Good Clinical Practices guidance.
  • Maintain inspection readiness for activities pertaining to labeling and distribution practices
  • Manage and resolve supply chain related issues such as temperature excursions, shipment related incidents, and other time sensitive issues
Requirements:

Requirements/Qualifications:

  • Bachelor's degree in supply chain management, logistics, pharmacy, engineering or related field; advanced degree (e.g., MBA, MS) or CSCP certification preferred
  • Minimum of 8-10 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 track record of effective collaboration and communication skills with internal partners and external providers.
  • Detailed understanding of Good Manufacturing Practices and Good Distribution Practices requirements, EP requirement, EU GDPs, Annex 13, CFR regulations, and ICH Guidelines governing conduct of clinical studies
  • Project management skills and expertise in outsourcing and vendor management
  • Experience and understanding of supply chain, including importation practices and customs clearance

Benefits:

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.



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