Associate Director / Director: Clinical Supply; Pharmaceutical Development

Ra Pharmaceuticals Cambridge , MA 02138

Posted 2 months ago

Ra Pharmaceuticals (NASDAQ: RARX), a clinical-stage biopharmaceutical company based in Cambridge MA, is focused on the discovery, development and commercialization of novel therapeutics based on its proprietary peptide chemistry platform. Ra is developing therapeutics to treat serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system. Ra Pharmaceuticals is assembling a team of highly motivated and experienced professionals who are committed to improving the lives of patients and building a world class biotechnology company.

POSITION DESCRIPTION:

Ra Pharma is looking to appoint a motivated leader of clinical supply management to contribute to the development of pharmaceuticals in the Ra pipeline. The primary purpose is to ensure the continuous supply of investigational medicinal product to the clinic. This role will manage all IMP packaging, labeling and device assembly as well as distribution, supply chain and supply depots. The Associate Director / Director of Clinical Supply will monitor and maintain inventory levels at supply depots and clinical sites as well as update and maintain IMP expiry. Further, this role will be responsible for forecasting clinical drug product demand and pre-commercialization drug supply activities such as defining and validating supply chain operations. This role is highly collaborative and cross functional, interfacing with the Drug Product Development, Clinical Operations, Technical Operations, Quality Assurance and Regulatory Affairs.

JOB RESPONSIBILITIES:

  • Demonstrated strategic thinking and planning ability

  • Forecasting IMP supply to ensure timely IMP production

  • Maintain drug product inventory accountability from depot to clinical site

  • Establish Clinical Supply Plan for each study

  • Collaborate with Clinical Operations to identify demand assumptions: enrollment rate, number of sites, number of countries, etc.

  • Collaborate with 3rd party clinical supply pack / label and IRT vendors to schedule and manage pack / label operations

  • Review clinical trial protocols and understand impact on clinical supply

  • Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Pharmaceutical Development and Clinical Operations for studies and/or programs

  • Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing capacity and regulatory requirements are considered and incorporated into manufacturing and supply plan

  • Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues

  • Manage label development process, expiration dating and updating as well as packaging timelines

  • Coordinate US and international distribution and logistics with CMOs

  • Develop IRT and participate in User Acceptance Testing

  • Participate in cross-functional Project Team Meetings

  • Develop and maintain applicable metrics

  • Review and update SOPs and identify the need for establishing new departmental procedures

REQUIREMENTS:

  • Bachelor's degree in life sciences or business major

  • A minimum of 7 years of pharmaceutical industry experience in supply chain management (rare disease and/or parenteral dose form (cold chain) preferred)

  • Experience in CMO management, including labeling, packaging, and distribution in North America and Europe

  • Experience with IRT/IWRS systems and implementation

  • Knowledge of cGMPs and relevant FDA and EU Regulations

  • Familiarity with US and EU regulatory agencies and their guidance

  • Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners

  • Ability to multi-task and work in a fast paced and dynamic environment

  • Strong organizational skills

  • Must be able to infrequently travel domestically/internationally

  • Direct supervisory experience is required

DESIRABLE SKILLS INCLUDE:

  • Demonstrated strategic thinking and planning ability

  • Demonstrated problem-detection and problem-resolution skills

  • Organizational skills with a proven track record of being self-directed while managing multiple projects

  • Excellent verbal and written communication skills; good interpersonal skills

  • Ability to drive external vendors to deliver quality results on time

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Associate Director / Director: Clinical Supply; Pharmaceutical Development

Ra Pharmaceuticals