Pre Clinical Safety Assesment Expert (Toxicologist) BASEL

Pre Clinical Safety Expert/ Senior Project Toxicologist - SWITZERLAND, BASEL - EARLY DEVELOPMENT COMPOUNDS.

OUR CLIENT IS AN ESTABLISHED PHARMACEUTICAL COMPANY WITH BROAD PRODUCT RANGE AND A STRONG EUROPEAN PRESENCE. IN THE HEART OF SWITZERLAND, THIS IS AN IDEAL LOCATION TO CONTINUE IN ESTABLISHING YOUR CAREER. THIS IS A SENIOR POST WHERE THE CANDIDATE WILL BE EXPECTED TO BE INVOLVED IN CROSS FUNCTIONAL PROJECT TEAMS.

As a Project Toxicologist/ Pre Clinical Safety Expert, you will manage the projects within the department and also liaise with cross functional project teams.

Conducts integrated safety assessment of non-clinical (toxicology) profile of pharmaceuticals in early and late stage development.

Assesses the relevance of non-clinical findings to human safety and implements safety measures.

Identifies potential safety hurdles, suggests solutions and establishes priorities and contingency plans in close collaboration with project teams and supporting line functions.

Capable in designing exploratory and regulatory safety studies, proficient in data interpretation and integration into overall safety assessment.

Establishes high quality development plans for assigned projects in collaboration with project teams and line function.

Monitors study timelines, objectives and budgets, ensures accuracy of project plans and assures rapid and effective communication of data after review to project teams.

Manages and coordinates relations with regulatory authorities, line function management, and drug regulatory affairs.

Leads sub-teams and/or line function specific teams.

Evaluates in-licensing opportunities.

Manages the preparation/presentation of all internal and external documentation (e.g. Investigator’s Brochure, IND, CTD).

Maintains scientific and regulatory expertise in the field of representing line function (e.g. training courses, external meeting attendance).

Experience & skills required

PhD in natural / biological sciences, DVM, or PharmD (desirable)
Fluent English (oral and written); German and / or French desirable
Substantial experience in conducting pre-clinical safety (toxicology) assessments
Advanced knowledge of general toxicology, safety pharmacology and reproductive toxicology including relevant regulatory environment
Ability to address and resolve toxicological issues arising in drug development programs
Experience in safety assessment of immunology, transplantation or autoimmune projects
Proven knowledge of drug development guidelines
Record of successful Health Authority Interactions
Ability to manage conflicting expectations in a matrix environment
Good project management skills, Team Player

For more information on this role please contact the Senior Consultant, Abid Kanji on 0207 940 2108 or email him at [Email ukryty]