Sr. Director, Clinical Develop - ReqCode 88968BR

Sandoz, a global leader in the rapidly growing generics industry, is a company in which doctors, pharmacists and patients worldwide have placed their trust for more than 100 years. With our 23,000-plus employees in more than 130 countries, we save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Choosing Sandoz is always 'a healthy decision'. Through our work and our medicines, we have committed ourselves to improving the quality of life of people the world over. Our future holds many opportunities. Let's explore them together!

Job Description:Summary

The Sr. Director of Clinical Development directs and manages global bioequivalence
requirements of products that are developed internally and externally. The Sr. Director
ensures that bioequivalence/clinical trials, associated bio analytical assays and final reports are consistent with Sandoz and FDA standards. The Sr. Director coordinates bioequivalence
activities with other Sandoz Departments or Affiliates to achieve timely submission of ANDA
and other regulatory filings. The Sr. Director prepares, manages, controls and maintains the
departmental budget. The incumbent represents the Department and provides scientific and
technical guidance to management and represents the Department in Corporate and FDA
meetings.

* Cooperates with fellow Sandoz corporation business units to effect and enable product
development that conforms to established global submission requirements.
* Represents Sandoz in meetings with FDA as a scientific and bio pharmaceutics/pharmacokinetics head.
* Assures highest quality studies from contract research organizations through competitive bidding and preferred provider agreements and site audits. Personally performs site audits when necessary.
* Represents department in corporate project review meetings.
* Trains and supports staff for professional growth.
* Manages and coordinates Bioequivalence activities on internal (in-house) projects.
* Manages and coordinates Bioequivalence study activities on external (outsourced products). Coordinates Bioequivalence activities with out-source development/manufacturing organizations and Sandoz to achieve desired ANDA submissions.
* Supervises staff including in carrying out necessary activities leading to timely ANDA
submissions.
* Reviews Bioequivalence sections of ANDA's. Provides scientific and technical guidance to
management on new bioequivalence technologies and suggests alternatives.
* Stays current with recent practices and trends in the generic pharmaceutical industries and regulatory policies. Acts decisively and makes sound decisions (after consulting with management) on bioequivalence study plan changes in order to achieve the competitive edge.

Supervisory

* The position reports to Vice President, Product Development position.
* This position has supervisory responsibilities. The position involves indirect supervisory
responsibilities.
Minimum Requirements:Competencies
A successful track record of progressive responsibility including leadership of others in
biopharmaceutics/clinical pharmacokinetics in a research and development within a generic
pharmaceutical environment. Demonstrated understanding of USP, FDA, and ICH
requirements for drug products and product development. Knowledge of generic product
development. Understanding procedures/software packages necessary for pharmacokinetic
calculations. Working knowledge of the Orange Book requirements for Bioequivalence
testing.

Qualifications
Adherence to all health, safety & environmental requirements in support of departmental
and site HSE goals. Work in a safe and efficient manner.

Education and Experience
A minimum of 15 years with an advanced degree in Biopharmaceutics and Pharmacokinetics
(Ph.D., Pharm.D. or equivalent) preferred.