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As a part of the Regulatory Affairs team, the Director will work with Department management and project team members to identify and execute regulatory strategies to support clinical development and commercialization of Ocular Therapeutix products globally. Execute project tasks relevant to regulatory affairs throughout product lifecyle(s). A unique position with exposure to medical device, pharmaceutical product development, drug / device combination products, advertising and promotion influence, non-clinical, clinical and CMC strategy support.
Execute routine and non-routine quality control testing activities as assigned by management. Take the lead on CAPA’s, change controls, investigations, and deviations. Participate in transfer of analytical methods to QC from both internal and external groups. Participate in testing, project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory.
The Director, Clinical Programs serves as an advisor to teams executing clinical studies. This position is also responsible for the performance of study sites and clinical vendors. The Director will work with study leads to ensure studies are inspection ready throughout their lifecycle. May serve as function lead when needed.
The Associate Clinical Project Manager assists with the execution of the coordination of activities associated with the set-up, management and closure of clinical studies and is responsible for the successful completion of studies on schedule and within budget.
Directs the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies. The QC group is comprised of the following functions: QC systems, Analytical Chemistry, Microbiology (including Environmental Monitoring), Method Validation, Stability and support. Provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality System.This position manages people and is responsible for all work completed within the QC group for pharmaceutical and medical device products across the entire product lifecycle.
Clinical research expert responsible for the co-development and execution of Medical Affairs scientific strategies spanning investigator initiated trials, clinical development studies (phase 1-4), and payer-informed research activities. Medical Directors contribute to the development of research questions, data analysis, interpretation, presentation, and publication of Ocular Therapeutix data across the Ophthalmology Scientific and Payer Communities.
The Clinical Document Specialist (CDS) will conduct clinical documentation tracking and trial master file activities. This position is highly visible and interactive with external vendors and cross-functional teams. In addition, the CDS plays a critical role in TMF management activities to ensure adherence to established processes and compliance with applicable global regulations.
As a member of the Quality Assurance team, establish, maintain and continually develop the Ocular Therapeutix quality management system to ensure product development and clinical activities are conducted in compliance with global GCP guidelines and the data generated from those activities is reliable. The role is responsible for ensuring the company is GCP inspection ready at all times.
As a formulation scientist, support the R&D team in designing and developing novel controlled release drug delivery products, from ideation, to prototyping and proof of concept evaluation. The ideal candidate will be self-motivated, work with a sense of urgency, and have a strong foundation in sustained drug delivery and formulation development for injectable and implantable dosage forms.
The candidate will be expected to execute research and development activities as assigned by management, including prototype, product, and processes development and documentation. May oversee the execution of project tasks relevant to R&D and monitor the activities and deliverables of project teams when in a leadership role
The Medical Statistician is an integral part of the Medical Affairs team, driving data generation and dissemination strategies across products and assisting in overall strategic planning. He/she will lead the development, coordination, performance, and validation of all statistical analyses in support of Medical Affairs, inclusive of overseeing the work of statistics and programming for external vendors as needed. He/she will also be accountable for working collaboratively with internal and external partners to apply statistical methodology to clinical trials across various trial phases and types, and act as lead statistician for key projects. Additionally, s/he will serve as the medical signatory on the internal promotional and medical review committees, ensuring all messages are medically accurate and appropriately cited. As an excellent communicator and collaborator maintain effective communication with clients, study teams, and other internal partners. Frequent cross-functional collaboration, both internal and external to the organization, is expected.
Work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Review batch records from production and testing and records for product development. Review, develop, and improve quality system procedures, specifications, and test methods. Process and provide oversight for elements of the quality system such as change control, deviations, CAPAs, and product complaints. May support investigations of quality issues or perform quality audits.
The Quality Systems Specialist II supports all activities within the Quality Systems team, including CAPA, Deviation and Change Control, and with a special focus on Document Control and Training. This includes, administering MasterControl, the electronic Document Management System (eDMS), supporting the document revision process, controlled document issuance, customer support, and establishment of training courses within the eDMS.
We are seeking an experienced and motivated R&D Engineer/Scientist to join our Drug Product Development Team. This individual is responsible for formulation, process development and scale-up of drug delivery candidates including the manufacture of preclinical and early phase clinical trial materials utilizing the company’s hydrogel-based drug delivery technology in concert with standard microencapsulation biodegradable polymer systems. In this role you will work collaboratively with group and cross-functional project team members and will oversee the execution of project tasks and activities when in a leadership role.