Sr. Scientist II -Toxicology

Glaukos Corporation • Aliso Viejo, CA

131d

About The Position

The Sr. Scientist II, Toxicologist reporting to the Sr. Director of Toxicology and Biocompatibility is responsible for providing subject matter expertise and leadership in toxicology and nonclinical development at the team and development project level.

Requirements

• 6 years minimum experience in medical device or pharmaceuticals.
• M.S. degree in Biological Sciences and/or toxicology with 10+ years of experience.
• PhD in Biological Sciences and/or toxicology with 6+ years of experience.
• At least 4 years of understanding and working with GLP and different laboratory animal species.
• Broad understanding of laboratory animal sciences, Good Laboratory Practices, laboratory animal care policies and FDA regulations.
• Skilled use of ocular anatomy, physiology and toxicology principles, theories and concepts.
• Excellent analytical and communication skills, both verbal and written.
• Excellent interpersonal skills, emotional intelligence and ability to negotiate.

Responsibilities

• Design, execute (including monitoring) and report on in vivo toxicology studies supporting the nonclinical development of new ophthalmic therapeutics and drug delivery devices.
• Contribute to the nonclinical development plan needed to satisfy clinical internal and regulatory requirements on a project basis.
• Participate in Project Team Meetings, interfacing with internal/external scientists from other disciplines.
• Author nonclinical study protocols and reports to support IND/IMPD/NDA/IMPD/PLA submission toxicology studies.
• Evaluate published/unpublished data and provide risk evaluation on new ingredients for regulatory submissions and clinical trials.
• Serve as a Study Monitor to ensure optimal testing requirements are implemented for each study.
• Provide interpretation and author research reports in compliance with GLP regulations to support the safety of new pharmaceutical, device, and combination products.
• Possess a comprehensive understanding and hands-on experience in conducting different study types in diverse laboratory animal species.
• Establish the development plan for nonclinical toxicity studies needed to satisfy clinical, internal and regulatory requirements.
• Schedule and execute toxicology studies based on project priorities to ensure orderly and timely progression within set target dates.
• Assume oversight for the technical conduct of studies and collaborate with the Study Director to assure compliance with Good Laboratory Practices (GLP) regulations.
• Evaluate CROs and obtain study bids/quotes, develop study protocols.
• Review and summarize study data to provide interpretation, conclusions, and recommendations.
• Review and approve the interpretation, analysis, documentation and reporting of results of nonclinical studies by CROs.
• Review and approve summaries of safety evaluations prepared for internal research release documents and regulatory agencies.
• Author relevant sections of regulatory documents (i.e. IND, NDA).
• Provide subject matter expertise and leadership in toxicology and nonclinical development at the team and development project level.
• Participate in project team meetings and provide scheduling and technical input.
• Evaluate available information/literature and provide technical expertise to assess and advise on the safety of new ingredients, compounds, acquisitions and competitor products.
• Prepare risk assessments and summaries for support of various research, clinical and regulatory activities.

What This Job Offers

• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees