Fellow Preclinical Safety Toxicology

The purpose of this position is to serve as the nonclinical subject matter expert (SME) in toxicokinetics (TK), pharmacokinetics (PK), pharmacodynamics (PD) and drug/chemical substance disposition (ADME) for ocular drug products. The incumbent will serve on multi-disciplinary product development project teams or sub-teams. This role will require significant collaboration with cross-functional colleagues in the delivery of ophthalmic nonclinical safety and TK/PK/PD/ADME strategies, plans and scientific data to support pipeline enhancement and development of novel pharmaceuticals in research, product development, product registration and post-market product support within a matrix environment.

•Provides expert technical leadership to project teams and nonclinical sub-teams and leads in designing, implementing and communicating nonclinical and regulatory toxicology and pharmacokinetics plans to support ocular pharmaceutical, nutritional and formulated over-the-counter product development (e.g., drug, quasi-drug, medical device and/or consumer health).

•Independently develops ophthalmic and systemic nonclinical and TK/PK/PD/ADME testing strategies (GLP and non-GLP) and project plans to profile candidate technologies, characterize and assess nonclinical safety, as well as provide tactical input into study designs using state-of-the-art methodologies for protocol development.

•Serves as key contact and SME for all nonclinical TK/PK/PD/ADME questions, makes decisions based on scientific data, and provides toxicology, pharmacology and drug/chemical substance disposition expertise to support assigned project teams or sub-teams.

•Proactively manages cross-functional interactions, ensuring that nonclinical PK/ safety information is effectively applied and integrated across the entire product life-cycle (ideation, feasibility / proof-of-concept, development, product registration and product support). •
Author nonclinical safety (risk) assessment evaluation technical documents and components of project summaries and development plans within pre-determined, agreed timelines that meet international and country-specific standards and regulatory requirements.

•Author nonclinical toxicology, pharmacology, and PK/TK/ADME sections of key documents including regulatory documents (e.g. IND, IMPD, CTD, NDA, MAA, IB), responses to health authority inquiries, and annual reports to regulatory agencies.

•Effectively analyzes, interprets, translates and communicates project and study-related results, hazard identification and risk assessment information, and risk mitigation recommendations Project Teams and Preclinical Development management.

•Applies expertise to develop and/or maintain nonclinical ophthalmology and systemic TK/PK/PD/ADME models, in vivo and/or in vitro, in collaboration with internal staff and/or through external partnerships.
Posting Title
Fellow Preclinical Safety Toxicology

Minimum requirements
• Fluent in verbal and written English communication skills.
• Bachelor's degree in a related field with (10+) years of directly related working experience OR equivalent combination of education and work experience.
•Proven experience as project lead for toxicology and pharmacology
•Proficient knowledge of ICH, USFDA, EMA guidance documents including GLP and GMP regulations.
•Experience in authoring regulatory submissions.
•Experience with the monitoring nonclinical studies at Contract Research Organizations.

Job Type
Full Time

Country
USA

Work Location
Fort Worth, TX

Functional Area
Research & Development

Division
ALCON

Business Unit
RESEARCH & DEVELOPMENT AL

Employment Type
Regular

Company/Legal Entity
Alcon Research, Ltd.

EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


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