Clinical Supply Specialist

Ocular Therapeutix•Bedford, MA

50d

About The Position

The Specialist, Clinical Supply Chain Management, will coordinate end-to-end supply chain management for multiple clinical programs within our dynamic and growing Supply Chain Management organization. This key role involves close collaboration with Clinical Operations, Regulatory Affairs, Quality, Contract Manufacturing Organizations (CMOs), Interactive Response Technology (IRT) and other vendors to lead supply activities for complex, multinational programs. As a pivotal point of contact, the successful candidate will ensure the seamless delivery of Investigational Product (IP) to our patients. They will thrive in a highly collaborative team environment, contributing to the successful execution of clinical trials and the advancement of our innovative therapies.

Requirements

Bachelor's degree, plus 1-3 years of work experience in a Supply Chain Planning role in a Biotechnology or Pharmaceutical environment.
Good understanding of clinical study design, execution, and drug supply management.
General knowledge of GxP processes and Global Country regulations for the pharmaceutical, biopharma or biotech industries.
Experience with RTSM/IRT systems and global drug supply demand planning.
Strong analytical, problem-solving, and communication skills (oral and written) to interface effectively with personnel at all levels inside and outside the organization
Strong collaboration and teamwork skills required for success in the highly cross-functional and multi-cultural environment.
Ability to work effectively and independently, as well as part of a cross-functional team.
Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient.
Excellent communication, collaboration, project management, and attention to detail.

Nice To Haves

Experience in cold-chain clinical supply distribution is a plus.
Experience with contract packaging and labeling organizations is a plus.

Responsibilities

Collaborate with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for developing supply requirements.
Create, review, and update clinical supply and demand plans based on strategic elements and study forecasts.
Coordinate product release with internal & external Quality, including QP Release.
Communicate project requirements with external partners.
Coordinate US and international distribution and logistics for clinical programs.
Participate in the development of IRT/RTSM User Requirement Specifications and User Acceptance Testing.
Monitor enrollment activity and inventory levels at depots and clinical sites throughout the trial lifecycle and action accordingly.
Track study status in IRT and intervene as necessary to ensure supply availability at clinical sites.
Troubleshoot problems with IRT as they arise, collaborating with IRT vendor as necessary.
Coordinate drug returns process, site close-out activities, and prepare drug reconciliation reports.
Update relevant Trial Master Files (TMF) with supply-related documents.
Review packaging and supply strategies to maximize efficiency and minimize waste, identifying risks and developing mitigation plans.
Support the label development process and packaging & labeling activities, as needed
Achieve operational objectives by contributing to strategic plans and budget reviews.
Collaborate with cross-functional teams on regulatory submissions and queries from Health Authorities.
Generate and review procedures and processes as required to ensure compliance to relevant SOPs, regulations, and laws.
Work with the supply chain and cross-functional team members to identify and implement continuous improvement projects.