Director, Scientific Affairs

DIRECTOR, SCIENTIFIC AFFAIRS




Barr Pharmaceuticals, Inc. a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develops, manufactures and markets more than 100 generic and proprietary pharmaceutical products in core therapeutic categories including female healthcare, oncology, cardiovascular, anti-infective and psychotherapeutic pharmaceuticals. The Company's generic products are marketed under the Barr label and proprietary products are marketed under the Duramed label. Barr is the leading supplier of oral contraceptive products in the United States.



In fiscal 2005, Barr recorded total revenue of $1.05 billion and invested $128 million in product research and development. Barr has operations in New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington, DC - and employs more than 2,000 employees.



We have an outstanding career opportunity for a successful Director, Scientific Affairs located in our Woodcliff Lake Office offices.

Responsibilities include:

Manage all human bioavailability and bioequivalence studies conducted by Contract Research Organizations for a subset of generic and proprietary drugs under development
Design bioequivalence and bioavailability studies that meet FDA requirements and Research and Development?s budgetary guidelines; primarily pharmacokinetic studies, but also pharmacodynamic and clinical endpoint bioequivalence studies
Write human pharmacokinetic sections of the NDA and product labeling for each NDA project assigned
Oversee work being done by Contract Research Organizations for each assigned product
Evaluate the protocols and other study documents being produced by the Contract Research Organizations
Guide efforts to develop in vitro dissolution methods predictive of in vivo performance, and assist in the evaluation and selection of final formulations for dosing
Evaluate preliminary data from a statistical and pharmacokinetic standpoint
Review and correct final bioequivalence and bioavailability study reports
Ensure that studies are properly designed and executed according to protocol on time and according to budget

Position Requirements include:

Master's degree, PhD, or PharmD and 7+ years related experience
Broad background in pharmacokinetics, pharmacology/drug metabolism, bioanalytical chemistry, biostatistics and in vivo-in vitro correlation; a high level of expertise is required in one of these fields
New Drug Application experience is preferred
Working knowledge of FDA guidances, regulations and practices
Capable of conducting research and evaluating data
Strong communication skills-both verbal and written




Commitment to Excellence - Many companies talk about it. Barr delivers - every day, to our customers AND to our employees. Barr's commitment to employees is reflected in our total compensation and benefits package that includes competitive salaries and incentive compensation programs, career opportunities offering both personal and professional growth; a 401(k) plan that matches up to an additional 10% of your pay each year; a stock purchase plan that allows you to buy company stock at 15% below market; comprehensive medical and dental plans that provide coverage for you and your family with nominal employee cost; life and disability protection programs and so much more! Together, we raise the BARR!




We are an Equal Opportunity Employer m/f/d/v.