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Ocular Therapeutix, Inc PK/PD Scientist in Bedford, Massachusetts

A highly motivated scientist to lead in the coordinating, executing, and documenting pharmacokinetics (PK) and pharmacodynamics (PD) pre-clinical studies which support preclinical strategy and clinical development efforts. These preclinical studies are performed at contract research organizations (CROs) assessing the PK/PD and safety of lead ophthalmic sustained release drug product formulation candidates. This person will further help design and execute studies working collaboratively with management and project team members supporting the companies sustained release hydrogel technology platform.

  • Coordinate, execute, document, and provide strategic input and scientific expertise on preclinical studies to understand PK/PD and safety of drug candidates.

  • Plan and manage activities at preclinical CROs to meet project needs

  • Responsible for the analysis, interpretation, integration and reporting of preclinical data.

  • Establish quantitative tools to translate PK/PD relationship from preclinical to clinical using both historical and current datasets.

  • Assist in the direction, management and oversight of bioanalytical method development, transfer, validation, and sample analysis supporting ophthalmic nonclinical and clinical studies.

  • Review and summarize results, integrate PK/PD information to guide multi-disciplinary team efforts in lead optimization and to facilitate selection of development candidates.

  • Collaborate effectively while participating in cross-functional product development teams to communicate study design, project status, data analysis and program plan to project team members including senior management.

  • Work within teams to meet project goals and proactively advise teams with a specific emphasis on leading effort to achieve preclinical goals and clinically relevant research.

  • Generate and/or review nonclinical study procedures, protocols and reports, and technical documents to support regulatory submissions.

Supervisory Responsibilities

  • None, but may functionally mentor and lead junior staff supporting drug product development preclinical activities dependent upon level and experience.

  • PhD in Pharmacokinetics, or related disciplines with 3+ years of relevant experience in the pharmaceutical industry; or MS with at least 6+ years of relevant experience; or BS with at least 8+ years of relevant experience.

  • Minimum of 3-5 years of experience in pre-clinical research, and familiar with GLP regulations, requirements, and standard study outputs.

  • Direct hands-on experience with in vivo studies involving animals is highly desirable.

  • Experience in supporting drug product elements of preclinical and early-stage clinical studies is desirable.

  • Experience in ophthalmic applications, routes of administrations and indications is a plus.

  • Proficiency in Phoenix WinNonlin or other PK software is required and familiarity with SEND data handling is beneficial.

  • Prior experience with regulatory submission (e.g., IND and/or NDA) is recommended.

  • Be able to travel to CRO sites for study coordination and execution (10-15%).

  • Excellent written and oral communication skills.

  • A hard-working, passionate about science, team player that can effectively collaborate in a dynamic, cross-functional team environment.

Working Conditions

  • Assistance in the handling (moving & lifting) of animals at contract laboratories when necessary.

ID: 2022-1572

External Company Name: Ocular Therapeutix, Inc.

External Company URL: http://www.ocutx.com/

Street: 15 Crosby Drive

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