R&D Leader

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 in excess of $2.2 billion. Merial Limited is a joint venture between Merck & Co., Inc. and sanofi-aventis. For more information, please see www.merial.com. 

 

Job Description:

The R&D Leader is responsible for planning and supervising research projects on a national and international scale. These projects represent components of one or more major worldwide research, pre-development, or development programs. The R&D Leader provides technical leadership to Project Teams and works closely with the Project Leader to direct the multi-disciplinary, multi-divisional team to complete the objectives of the development program. 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. The R&D Leader provides up-to-date information concerning project status, disease and production trends, and regulatory environment critical to departmental strategic planning.

1. Functions as an R&D Leader for several projects within Pharma R&D Projects. Projects may involve research, pre-development, or development product candidates.
2. Develops and implements models appropriate for screening and evaluating efficacy and safety associated with the desired product claims.
3. Prepares Product Development Documents, Protocols, Statements, Clinical Experience Reports, Freedom of Information Summaries, responses to regulatory “incomplete” letters and other documents for INAD and NADA submissions for projects under his/her direction.
4. Interacts with other department and division personnel such as Discovery Research, R&D Projects, Clinical Operations, preclinical research within shareholder companies, Formulation Development, Regulatory Affairs, Analytical Research & Development, Pharmacokinetics & Drug Metabolism, Project Planning, Global Strategic Marketing, and Industrial Operations on project-related matters.
5. Is responsible for all technical aspects of Project Team meetings, participates in other selected interdepartmental meetings, and may be required to represent the department at management meetings.
6. Represents the department in face-to-face and teleconference discussions with regulatory agencies concerning projects under his/her direction.
7. Insures that all 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.
8. Reports adverse reactions to company products within the incumbent’s area of responsibility according to company procedures.
9. Reviews and approves labeling, promotional and publication materials related to projects under his/her direction.
10. Maintains knowledge of competitive developments that may impact on the commercial viability of candidate products, and recommends strategies to combat their effects.
11. Provides product surveillance and technical service support when required, particularly during the immediate (6-12 months) post-launch period.
12. Appraises opportunities for licensing-in products and makes appropriate proposals to management.
13. Initiates proposals and evaluates grant-in-aid requests submitted by outside investigators. Responsible for coordination and maintenance of grant budgets for the projects involved.
14. Utilizes opportunities for publication and presentation of research data and encourages others in Merial and independent investigators to do the same.
15. Encourages continuing education in the department through coordination of seminars and other educational opportunities.
16. Provides input to management for profit plan development for the projects under his/her direction.
17. Must exercise discretion and judgment when discussing product development in a commercial environment in order to maintain confidentiality and exclusivity of future company products.
18. The incumbent may be required to travel on company business about 20% of the time.

 

Qualifications:

 Minimum: DVM (or equivalent) and 6 years of experience in a field of veterinary medicine.
 Preferred: DVM (or equivalent) plus MS and/or PhD and 3 years of experience in a field of veterinary medicine.
Type of experience:
 Basic or clinical research in a pharmaceutical-related industry/university/institutional research setting.
 Resource and financial planning of complex projects are desired.
Knowledge and skills:
 Solid working knowledge of basic science and the drug development process.
 Ability to perform in a team setting and matrix 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