SR Scientist, Toxicology

Duties & Responsibilities

• Independently initiates and coordinates strategic scientific experiments with a predefined goal including developing new methodologies, protocols and/or test procedures that contribute to core group/research goals and reflect expert knowledge.
• May direct and oversee experimental study design and data analysis/results of and junior-level scientists.
• Provides accurate and timely internal technical reviews, position or white papers, data summaries, and risk assessments based on critical analyses of literature and data.
• Develops an understanding of R&D team goals and works effectively toward achieving them. The individual assumes departmental responsibility for projects within multi-disciplinary international development Core Teams for the effective development of pharmaceutical projects.
• Interacts with International Project Leaders within the Core Team in reporting of project progress, including budgetary responsibilities to steering committees.
• Supports team in authoring, for US and International regulatory submission and evaluation, company safety and pharmacology documents in support of new product registrations, due diligence reviews, new in-line claims and registration maintenance for in-line products across all franchises.
• Prepares clear technical reports, publications and oral presentations.
• Independently communicates results in the form of reports and/or presentations.
• Presents responsibly and defends own work at meetings.
• May deliver updates to senior-level management in context of overall project goals.
• Contributes and presents project related topics within Regulatory forums (FDA).
• Discusses technical strategies with Director and implements the plan.
• Develops expertise in a specific project-relevant area or technology.
• May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects.
• Independently identifies contract laboratories; Sponsor Representative for outsourced toxicology studies; maintains testing costs and testing timelines.
• Keeps abreast of relevant literature. Develops visibility outside of functional area and effectively interacts scientifically with Key Opinion Leaders in relevant fields of concern.
• Effectively liaises internally with cross-functional stakeholders (Sales & Marketing, Legal, Finance, Operations), to communicate and align expectations.
• Represents Drug Safety and DMPK on Research and Development project teams.
• Complies with all applicable regulations.
• Ensures that work performed in area of responsibility is conducted in a safe and compliant manner.
• Maintains proper records in accordance with SOPs and policies.
• Contributes to departmental administration; demonstrates fiscal responsibility with respect to cost of experiments/studies, technology, external collaborations and travel.
• Manages study budgets (<$5M) and follows internal processes to execute financial responsibility.
• Responsible for ensuring that exposure limits for the animal health portfolio are generated and in compliance with Corporate policies governing their generation.

Requirements

• PhD in toxicology or related discipline is required, with at least five (5) years of relevant experience; ABT certification is preferred.
• Understanding of Good Laboratory Practices.
• Experienced in conducting/monitoring a variety of GLP-regulated safety studies in multiple species.
• Understanding of analytical and bio-analytical testing requirements.
• Critical data analysis/problem solving skills.
• Strong technical oral and written communication skills.
• Able to conduct non-toxicology related assignments.
• A thorough understanding of bench, applied and regulatory toxicology in drug development process is required.
• Good interpersonal skills to ensure contribution to multi-disciplinary product development teams are also necessary.
• Research methodology experience.
• A minimum of five (5) years of broad experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization or equivalent combination of education and experience.
• Demonstrates industry-leading knowledge of field.
• Ability to communicate effectively both orally and in writing in an inter-disciplinary environment.
• Demonstrated knowledge of the R&D life cycle process.
• Experienced in project/program management.
• An analytical thinker.
• Exhibits business and technical knowledge.
• Fosters innovation.
• Outstanding communication skills.
• Possesses a customer service orientation, delivering results and executing in a fast and focused manner. A problem solver.
• Exceptional planning and organizational skills with a quality orientation. Strives for business process excellence.
• A collaborative team player. Values diversity and inclusion.
• Accepts accountability and ownership.
• Exhibits integrity and trust.
• Board Certification a plus.