Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
Position Summary:
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.
Principal Duties and Responsibilities include the following:
- 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.
Qualification 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.
- Experience in cold-chain clinical supply distribution is a plus.
- Experience with contract packaging and labeling organizations is a plus.
- 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.
Working Conditions
- Domestic and international travel required, up to 25%
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.