Senior Director

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.

Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.



Position Description:

The Associate Therapeutic Axis Head (ATAH) is part of the Product Development and Life Cycle Management (PDLCM) leadership team, and works closely with the Therapeutic Axis Head (TAH) to provide input for development of global strategies and implementation as an integral part of the therapeutic axis management team. The ATAH is responsible and accountable for the fulfillment of the mission and the achievement of the goals of the therapeutic axis within their territory.

Duties/Responsiblities
1. To lead and set the environment of therapeutic area by working with Sanofi-Synthelabo management and Regulatory Authorities worldwide
2. To ascertain and understand the rationale for developing a compound as well as the existing and projected external regulatory environment through the project representatives, TAH, and appropriate senior management
3. To ensure the integration of these concepts into global regulatory strategies for each project by providing options, recommendations and proposals for final decisions by TAH.
4. To ensure the effective and successful tactical implementation by the project teams through the project representatives.
5. To work with the TAH to develop and ensure the timely and effective management of budget.
6. To work with the TAH to develop and ensure the effective management of personnel, including training, professional development and mentoring within the therapeutic axis to enhance the capabilities of the axis.


To Apply Visit Sanofi Aventis

Qualifications:

Knowledge/Skills
?Strategic assessment skills?Ability to negotiate by influence and coach others in these skills.?Scientific understanding of basic physiology, pharmacology/biology, pharmacokinetics, role of preclinical studies in drug development.?Scientific understanding of clinical study design and endpoints, and statistical analyses and power calculations.?Thorough understanding of drug development requirements and processes.?Understanding of therapeutic area and US and EU guidelines/points to consider available to assist in writing development and regulatory plans.?Working knowledge of regulatory requirements for IND/IMPD/CTX and CTD/NDA/MAA requirements for filings in US and Europe.?Understanding of practical regulatory requirements for submission in Europe through mutual recognitions and centralized procedure.?Understanding of the regulatory and legal aspects of region?s (US or Europe) laws and regulations.?Advanced understanding of principles of statistics for both preclinical and clinical studies, including regression analyses, met analysis, etc.?Understanding of GLP, GMP and GCP requirements in EU and US.?Excellent written and oral presentation skills?Management skills for development of teamwork, budgeting, planning, performance evaluation and coaching, and interviewing skills.?Ability to lead teams for regulatory aspects of drug development.

Formal Education/Experience
PhD. or MD with at least 5-6 year regulatory experience including OncologyMS with 5-8 years regulatory experience including OncologyBS with 8 + years regulatory experience including Oncology