Preclinical Leader/Senior Toxicologist

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,000 people and operates in more than 150 countries worldwide. Its 2006 sales were nearly $2.2 billion. Merial Limited is a joint venture between Merck & Co., Inc. and sanofi-aventis.  For more information, please see www.merial.com

Preclinical Leader/Senior Toxicologist

The Preclinical Leader/Senior Toxicologist is responsible for the planning and supervising of preclinical proof of concept (PoC)/efficacy projects and the facilitation of in vivo and in vitro preclinical safety screening projects of formulations and molecules in discovery, research or predevelopment. These projects represent components of one or more major worldwide pre-development programs. The Preclinical Leader provides preclinical technical leadership in the Research Projects Team (RPT) for opportunity evaluations governed by the Innovation Review Committee (IRC), in support of the Discovery Research Process (DRP). The Preclinical Leader works closely with the RPT members, Clinical Leaders and Toxicologists. Successful completion of a project with subsequent registration of one or more product claims represents a significant contribution to Merial sales, potentially contributing $10-100M in sales to the company portfolio.

Major responsibilities:
1. Functions as Preclinical Leader for several projects within Clinical R&D in support of IRC and DRP objectives. Projects will involve discovery, research, and pre-development product candidates. Projects may involve safety screening, or proof of concept/efficacy studies. In this capacity, the incumbent may supervise others (e.g., Toxicologists, Clinical Operations personnel, Research Coordinators/Biostatisticians) assigned to the projects.
2. Develops and implements PoC models appropriate for evaluating the efficacy and safety associated with the desired product claims.
3. Prepares Protocols, Procedure Statements, Study Reports for projects under his/her direction.
4. Interacts with other department and division personnel such as Discovery, Formulation Development, Analytical Research & Development, Pharmacokinetics & Drug Metabolism, Regulatory Affairs and Industrial Operations on project-related matters.
5. Is responsible for leading RPT meetings, participates in other selected interdepartmental and management meetings.
6. Insures that all preclinical PoC/efficacy and safety studies, whether within the company or with independent investigators, are conducted in accordance with regulatory guidelines, and that federal, state and local requirements are met.
7. Maintains knowledge of competitive developments that may impact on the commercial viability of candidate products, and recommends strategies to combat their effects.
8. Responsible for coordination and maintenance of resource and financial budgets for the preclinical projects involved.
9. Encourages continuing education in the department through coordination of seminars and other educational opportunities.
10. Provides input to management for profit plan development for the projects under his/her direction.
11. Must exercise discretion and judgment when discussing preclinical or pre-development projects in a commercial environment in order to maintain confidentiality and exclusivity of future company products.
13. The incumbent may be required to travel on company business about 20% of the time to attend meetings, visit scientific personnel, and visit clinical investigators and trial locations.

Education and years of experience:
 Minimum: DVM or PhD and a minimum of 7 years of experience in a field of veterinary medicine or toxicology/pharmacology.
Type of experience:
 Clinical research or applied toxicology testing in a university or CRO setting preferred.
Knowledge and skills:
 Solid working knowledge of basic science and the drug discovery and development process;
 Working knowledge of writing human health risk assessments;
 Ability to perform in a team setting and matrix management environment;
 Ability to help build consensus in a group setting is a critical skill;
 Excellent writing, editing and interpersonal skills;
 Excellent computer skills including Microsoft Project, Word, Excel, and Outlook;
 Ability to use reasoning and negotiation skills to resolve project issues.

EEO/AA/M/F/D/V