Main duties and responsibilities

• Direction, management, and organization of pre-clinical studies: Responsible for the conduct of the deadlines and standards. Develop synopses of studies, protocols and participate in planning. Supervise and coordinate internal activities required for the initiation, conduct, and completion of studies on site.

• Technical support: Report and interpret the experimental results, deviations to the protocol and other features. Validate that all the experimental data are properly collected, verified and stored.

• Quality Control of pre-clinical studies: Control the implantation of activities in compliance with GLP, the SOP and regulations related to ethics. Implement corrective measures, monitor transfer of data, participate in audits.

Education, knowledge and skills

• The ideal candidate will have an advanced degree in Pharmacy, Veterinary, or Medicine with specialization in Toxicology or related discipline. Diplomat of the American Board of Toxicology (DABT) preferred. Ten years’ experience in toxicology monitoring, especially in (sub)chronic and developmental toxicity studies required. Five years’ experience in a Contract Research Organization (CRO) environment as Manager or Senior Study Director would be an asset, as incumbent will support the in-house studies and related activities for international sponsors from the cosmetic, chemical, agrochemical and pharmaceutical industries. Equivalent combinations of an advanced degree and experience may be considered.

• Prior experience managing and leading teams including organizational design, developing personnel and managing team and individual performance (Study Directors, Technicians).

• Broad working knowledge of major global regulation and registration requirements (REACH, cosmetics, pesticides, biocides, agrochemicals, pharmaceuticals,..), with primary emphasis on EU, Brazil, US and China.

• Diverse experiences in the areas of influencing regulations and regulators, and managing compliance issues.

• A record of integrating regulatory and regulatory sciences knowledge that helps lead multi-disciplinary teams to creative solutions.

• A history of creating strong relationships globally with partners and key customers to develop and execute regulatory plans in support of mutual goals and objectives.

• English fluency is imperative (written & spoken). Knowledge of Portuguese is an additional asset.

• Expert knowledge of the scientific process and exceptional laboratory practices are required.

The company

With over 40 years of experience an part of the Institut Mérieux, Mérieux NutriSciences helps advance science and solutions for food safety, quality and nutrition worldwide. Through its business units Bioagri, Silliker, Biofortis, it provides consulting, testing, auditing, education, sensory, innovation and contract research services. Bioagri is the dominant research laboratory in Latin America for environmental, pharmaceutical, chemisty analysis and food technology.

Present in 16 countries through more than 60 laboratories and 4,000 employees, Mérieux NutriSciences’ vision is to improve health through better nutrition and safer good. Our vision is realized by our dedicated staff and their commitment to our four core values: Excellence, Integrity, Initiative and Accountability.

Join us by sending your resume and cover letter to:

bill.davidson@silliker.com