DescriptionThe Senior Scientist, Toxicology independently plans strategies for studies to reach goals and milestones. Designs and executes experiments to meet product goals and to fulfill regulatory requirements. The incumbent fulfills a role as a subject matter expert in representing his/her function and providing communication on core teams. This role contributes technical approaches and scientific support to regulatory affairs in meeting regulatory requirements. The primary scope of responsibility is as a technical leader within their immediate function and secondarily within a multidisciplinary project team.
The Senior Scientist, Toxicology ensures the safety, including environmental, of BIAH products in the R&D pipeline, and supports globally marketed products. This role supports the Director in the conduct of toxicological evaluations of formulations in research, as well as their active pharmaceutical ingredients and excipients. The incumbent implements and reports safety studies to support research and development of new products, claim extensions and in-line products as well as authors safety health risk assessments. You will also establish and review occupational exposure limits and permissible daily exposure limits for BIAH products.Represents Safety Assessment on Research and Development Project Teams. This role represents Safety Assessment on Research and Development Project Teams.
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.
- Ability 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.
Eligibility Requirements :
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
