Toxicologist, Preclinical Safety Assessment - R&D

Date: 09-Aug-2022

Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

Company: Almirall

Mission

Overall leadership, operational management and scientific direction of toxicology projects in research, reformulation/repositioning and development.

Tasks and Responsibilities

1.  Develop toxicology strategies and provide toxicological expert support to research and development projects
2.  Responsible for toxicology activities in Project Teams ensuring that are completed with high quality standards and within approved budgets and timelines.
2.   Guidance and management of non-GLP and GLP toxicology activities
•    Take responsibility as preclinical project lead for selected research or development projects.
•    Responsible for the management of outsourced studies (budget, quality, timelines, etc.)
•    Contribution to Project Teams strategy and execution plans
•    .Plan, monitor, analyze and report preclinical safety pharmacology and toxicology studies conducted in collaboration with external contract research organizations (CROs) for selected projects.
•    Provide technical input to the regulatory process and interaction with international Regulatory Agencies.  Prepare and review non-clinical documents as part of regulatory submissions and interactions.
3.   Ensure that Pharmacokinetics and Drug Metabolism are fully integrated in the activities of safety assessment.
4.   To provide advice to Pharmaceutical, Clinical and Regulatory Affairs departments, as well as to other business divisions of the company, to support the safety/risk assessment of products in development or marketed product.
5.   Toxicology support to the industrial area (toxicology, occupational risks, ecotoxicology, etc.). Manage and prepare toxicological risk assessments to support drug development and manufacturing.
6.   Support Business Development in- and out-licensing activities.
7. To conduct Target Safety Assessment internally or in collaboration with external CROs of the target of interest through the review among others of its biological function, expression profile, organ distribution and species variation.

Education

•    Bachelor degree in Pharmacy or related life sciences.
•    Depth knowledge of Toxicology or related discipline, PhD , desirable
•    In depth knowledge of relevant regulatory guidelines.
 

Specific Knowledge

•    Science-driven, independent worker with the ability to adjust well in a changing environment
•    Pro-active, solution-oriented  and performance-driven
•    Excellent communication and analytical skills
•    Strong planning and organizational skills
•    Capability to build and maintain networks
•    Proven ability of working in complex multi-disciplinary settings
•    High level of English (oral and written), essential.
 

Experience

In depth knowledge of the pharmaceutical industry with at least 3 years of experience in drug development or as non-clinical toxicologist