Sr. Scientist II -Toxicology

Sr. Scientist II - Toxicology

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.

What You'll Do:

• The design, execution (including monitoring) and reporting on in vivo toxicology studies supporting the nonclinical development of new ophthalmic therapeutics and drug delivery devices and contributing to the regulatory submissions enabling their testing in clinical studies. These studies include safety/tolerability testing of novel formulation in nonclinical models.
• Contribute to the nonclinical development plan needed to satisfy clinical internal and regulatory requirements on a project basis.
• Participate in Project Team Meetings, and interfacing with internal/external scientists from other disciplines.
• Authors nonclinical study protocols and reports to support IND/IMPD/NDA/IMPD/PLA submission toxicology studies.
• Evaluating published/unpublished data and providing risk evaluation on new ingredients for regulatory submissions and clinical trials.
• Serving as a Study Monitor to ensure optimal testing requirements are implemented for each study. Providing interpretation and authoring research reports in compliance with GLP regulations to support the safety of new pharmaceutical, device, and combination products.
• Possessing a comprehensive understanding and hands-on experience in conducting different study types in diverse pre-clinical settings.

Design and execute nonclinical toxicity study plans 40%

• Establishes the development plan for nonclinical toxicity studies needed to satisfy clinical, internal and regulatory requirements. As Study Monitor, designs studies to maximize the quantity and quality of data and ensure adequate safety information is obtained from the study. Schedules and executes toxicology studies based on project priorities to ensure orderly and timely progression within set target dates.
• When acting as Study Monitor, assumes oversight for the technical conduct of studies and collaborates with the Study Director to assure that all aspects of studies are performed in accordance with Good Laboratory Practices (GLP) regulations, when specified, as mandated by the FDA. Serves as key contact for outsourced studies and assures that studies are executed according to protocol, SOP and contract.
• Evaluates CROs and obtains study bids/quotes, develops study protocols.

Data review and reporting 40%

• Reviews and summarizes study data to provide interpretation, conclusions, and recommendations.
• Reviews and approves the interpretation, analysis, documentation and reporting of results of nonclinical studies by CROs to assure accurate safety assessments of drugs and devices.
• Reviews and approves summaries of safety evaluations prepared for internal research release documents, regulatory agencies (IND summaries) and clinical investigator brochures.
• Authors relevant sections of regulatory documents (i.e. IND, NDA)

Interdepartmental and project team participation 15%

• Provides subject matter expertise and leadership in toxicology and nonclinical development at the team and development project level.
• Participates in project team meetings. Provides scheduling and technical input and plays an integral role in the project functional development plans.
• Proactively communicates with the team leaders and members on a regular basis and promptly notifies functional head and team leaders of issues.

Scouting, new opportunity evaluation 5%

• Evaluates available information/literature and provides technical expertise to assess and advise on the safety of new ingredients, compounds, acquisitions and competitor products.
• Prepares risk assessments and summaries for support of various research, clinical and regulatory activities. Exercises good judgement in recommending issues related to safety.

How You'll Get There:

• 8 years min. medical device or pharmaceuticals
• M.S. degree in Biological Sciences and/or toxicology with 10 years of experience.
• A PhD Biological Sciences and/or toxicology 8 years of experience.
• At least 4 years of understanding and working with GLP and working in a pre-clinical setting.
• Broad understanding Good Laboratory Practices, care policies and FDA regulations, is desired. 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.
• Some travel required