Director, Toxicology and Biocompatibility

TheDirector, Toxicology and Biocompatibility provides scientificdirection for the nonclinical strategy including preclinical toxicology and biocompatibility studies to enable the pharmaceutical drug and combination product development and the submission of INDs, IMPDs, NDAs and MAAs in accordance with regulatory expectations for novel small and large molecule ophthalmic therapeutics and extended duration drug delivery systems.

This individual will lead a team of experienced scientists responsible for the design, execution, and interpretation of the nonclinical safety studies conducted in the relevant toxicological species and biocompatibility studies in accordance with current regulatory expectations and assures that the nonclinical program supports the clinical development plan including the assessment of clinical pharmacology (systemic drug exposures, potential biomarker evaluations, in vitro in vivo correlations).

The individual will work closely with the early research teams, cross-functional project teams, regulatory, and clinical to coordinate and manage nonclinical activities that expedite the entry of target candidates into clinical trials and to provide continued support to clinical candidates. These include planning, and execution of external GLP toxicology and non-GLP tolerability studies, as well as biocompatibility assessments to support development programs. Reviews, summarizes and integrates complex data sets across multiple disciplines. Mentors direct reports in the development of relevant animal models for efficacy and safety and design of studies generation of quality research reports and integrated summaries included in the regulatory submissions.

Manages, directly and as a supervisor, the preparation and presentation of nonclinical safety and biocompatibility data for project teams, portfolio management presentations, and internal /external partners and scientific groups. Provides strategic advice to project teams and senior management including evaluation of conclusions and potential impact of results on program and clinical/regulatory strategy.

He/she will oversee the contract research organizations (CROs), the related study monitoring activities, plans and manages the nonclinical study budgets and assures timely and compliant delivery of external study reports. Partner and network with nationally and internationally recognized leaders/consultants

What You'll Do:

• The ability to develop, execute, and lead a sound science-based nonclinical toxicology and biocompatibility evaluation plans to support clinical development is a critical part of this position.
• Design scientific approachesand use best industry practicesinnonclinical toxicology study designs.
• Possess a broad technical experience/expertise across the following disciplines:
• ophthalmic drug development for the front and back of the eye, (NCEs and biologics), knowledge of relevant animal models, maintain and develop understanding of toxicology, biocompatibility and the related disciplines in ADME-PK and bioanalytical.
• Manage authors and/or the assembly of expertise specifically nonclinical sections of regulatory filings.
• Provide strong technical leadership and activity management with CROs and assure that testing activities are in compliance with current GLP and regulatory requirements.
• Ensure all development reports are completed timely to support regulatory filings.
• Collaborates effectively withinApplied Research, and with Vision ID, Clinical, Regulatory, CMC.
• Strategically manages the team in response to project load leveraging internal and external resources..
• Directly and indirectly manage staff with coaching, goal-setting, and performance assessment.
• Maintains current understanding of regulatory requirements and FDA and ICH guidance for the conduct of nonclinical and biocompatibility assessments enabling 505(b)1 and 502(b) 2 regulatory strategies.

How You'll Get There:

• 12+ years relevant industry experience
• 4+ years of successful management experience in related industry
• The ideal candidate has current DABT certification
• Previous experience in areas of ophthalmology with an understanding of corresponding animal models of disease and associated translational aspects of drug development
• Experience in designing, monitoring, interpreting and effectively communicating results of nonclinical safety studies and managing study budgets.
• Experience in developing toxicology and biocompatibility programs to support early and later stage drug development and in preparing regulatory filings such as INDs/CTAs/NDAs/MAA
• Strong understanding of compliance guidance documents and GLP regulations
• Excellent verbal and written communication skills
• Previous experience and excellence in managing people, both directly and cross-functionally, and creating teams to support non-clinical programs.
• Problem solving and organizational skills with attention to detail.
• Strong team player and strong motivational skills.
• Must be able to critically evaluate written and published pharmacology/toxicology documents for overall quality and acceptability of scientific interpretations.
• The preferred candidate has a PhD, postdoctoral training