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Job #02363

About our client Our client is one of the world’s largest generic pharmaceutical companies. It is a leader in developing, manufacturing and selling of high quality generic pharmaceuticals. Incorporated in the early '50s, the company operates across five continents and has 10,000 employees across 30 countries. Position Location Director of Clinical Development Elizabeth, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage budget, placement and timeline of all clinical studies 2) Identify and manage CROs, clinical consultants and other related third party entities 3) Oversee all aspects of developing and writing clinical protocols and outlines 4) Ensure all clinical studies are conducted in accordance with Good Practices 5) Discuss trial design and results with team members 6) Perform pharmacokinetic analysis and bioequivalence testing 7) Provide leadership and direction to clinical activities 8) Prepare clinical study plan, protocol design and select CROs 9) Assess study results to meet regulatory and scientific objectives 10) Create and implement clinical development studies, including medical and scientific assessment of the clinical data 11) Monitor changes in the regulatory/medical environment Requirements 1) Ph.D or M.D. degree with experience in conduct of clinical studies 2) Experience in semi solids and liquid dosage form highly preferred 3) 5+ years of pharmaceutical industry or related experience 4) Clinical research and/or drug development experience in semi solids and liquid dosage form 5) Generics, dermatology experience 6) Medical background preferred 7) Pharmaceutical industry experience is preferred 8) Experience in designing protocols 9) Experience in managing a CRO 10) Knowledge of FDA regulatory guidance 11) Knowledge of Good Clinical Practices and ICH guidelines 12) Ability and willingness to work in a cross-functional team environment 13) Good project management skills 14) Willingness to travel