Director Clinical Research job in New York, USA

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Job type: Permanent

Discipline: Clinical Research Associate (CRA), CRA Manager, Program Manager / Director

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Director of Clinical Research for a leading biotechnology company located in New York. As the Clinical Research Director, you will p articipate in activities related to protocol data review, medical monitoring, query resolution, and study conduct oversight

Job Responsibilities:

Contribute to and/or lead the development of clinical protocols and other clinical documents, in close collaboration with cross-functional team members and external vendors
Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Provide scientific review of statistical analysis plans
Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities
Collaborate on the review, analysis, and interpretation of study results, including exploratory endpoints
Collaborate with team members in Data Management activities such as development of eCRFs, edit checks, report development and database lock processes
Assist in writing and providing scientific input, review, and edits of clinical study reports, Investigator Brochures, INDs, NDA annual reports, integrated medical reports, and other regulatory submissions
Support preparation of abstracts, manuscripts, presentations, and materials for external meetings as it relates to the assigned protocol(s) and/or clinical program

Skills and Requirements:

Doctorate degree (e.g. Pharm.D., Ph.D.) with 3+ years of experience in clinical development in the pharmaceutical/biotech industry, particularly in Phases II-III, 5+ years of experience for BS/MS degree
Prior dermatology drug development experience preferred
Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
Excellent written and oral communication skills
Ability to multi-task and to work successfully in a lean, fast-paced, matrix team environment
High level of organizational and project management skills.
Travel requirement approximately 5-10% based on protocol development stage and program need

If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or n.aganon@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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