Director of Clinical Development

Director of Clinical Development

Glen Allen, VA

Direct-Hire

 

Our client, a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders, is seeking a Director of Clinical Development that will oversee all aspects of clinical development within the company to ensure the success of clinical trials. This is a direct-hire position located just outside of Richmond, VA.

 

Responsibilities include, but are not limited to:

 

?  Overall responsibility for operational aspects of all clinical development programs within the company.

?  Manage global development plans, including protocol development, clinical trial conduct, and assistance with regulatory filings.

?  Develop and manage budgets for all clinical programs.

?  Ensure timely initiation and recruitment of clinical studies.

?  Ensure appropriate implementation of all clinical protocols and management of protocol amendments and deviations.

?  Provide operational input into regulatory and clinical strategy.

?  Develop and/or review all protocols, Sample Informed Consent Forms, abstracts, presentations and manuscripts.

?  Manage and supervise all clinical operations staff (clinical project managers, project administrative assistants and CRAs). Identify and manage fiscal and human resource needs for operational aspects of clinical programs.

?  Participate in selection of and take responsibility for oversight and management of outside contractors (contract research organizations (CRO), central laboratories, independent contractors, etc.) and investigator sites, including negotiation of contracts with these parties.

?  Provide senior management with timely updates on progress and changes in scope, schedule, and resources.

?  Manage clinical advisory boards to support development of the company?s key clinical goals.

?  Ensure all clinical development activities meet cGCP regulations.

 

Requirements:

 

?  The successful candidate will have a Bachelors/Masters degree in a scientific discipline or the equivalent experience. An advanced degree is preferred.

?  Candidates should possess a minimum of 8-10 years of clinical research /pharmaceutical industry experience.

?  He/she should have extensive knowledge in Pharmaceutical Development, including demonstrated working knowledge of details and issues involved in clinical operational aspects of drug development, familiarity with IND/NDA filings, logistics, and cGCP regulations.

?  Versatility and flexibility, superior communication, organization, negotiation, and project management skills are essential.

?  Must have the ability to work with a multi-disciplinary team of professionals.

?  Some long-distance/overnight travel will be required.

 

Metropolitan Research Associates is a full service CRO and clinical research staffing firm that offers expertise in all areas of clinical development for the pharmaceutical, biotech, and medical device industries.

 We offer a very competitive salary and benefit packages. For more information about our job opportunities and MRA or to submit your resume, visit us at www.metropolitanresearch.com or fax to 919-510-7914.