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Associate Director, Clinical Affairs Job
Date: Nov 5, 2009
Location: Madison, NJ, 07940, USA
Job Title:
Associate Director, Clinical Affairs
Req #:
5368BR
Job Description:
Position Summary: Participate in pharmaceutical project development teams and facilitate regional and global clinical development. Accountable for expert ophthalmic contributions including the identification and evaluation of clinical scientific issues related to clinical trial implementation. Interpret clinical data and contribute to clinical study reports and related documentation required for pharmaceutical clinical development. Specific
Job Duties:
. Participate on pharmaceutical R&D teams as a clinical scientific representative. . Provide scientific expertise for pharmaceutical clinical development with respect to the planning and execution of clinical trials, including cross-functional collaboration and communication and global clinical scientific representation. . Provide input and oversight for all clinical scientific aspects of registrational trials including safety, tolerability and efficacy reporting. . Participate in global clinical development meetings, contribute to harmonized protocol designs, participate in and present clinical data during internal and external meetings and symposia. . Develop and maintain strong scientific relationships with medical experts in support of clinical development programs. . Manage all clinical scientific aspects of pharmaceutical clinical trials. . Ensure compliance with FDA regulations, GCP and ICH guidelines. . Identify and evaluate clinical scientific issues related to projects and implementation of sound resolutions. . Provide input on R&D departmental decisions related to processes and procedures.
Qualifications
Qualifications: .
Education:
MD or PhD required (MD, Ophthalmology preferred) . Experience: Minimum 5 years research, clinical trial or related experience. Must have excellent communication, organizational, and writing skills. .
Special Skills:
Experience with ophthalmic pharmaceuticals for the treatment of glaucoma and dry eye preferred. Demonstrated ability to train study personnel and study CRAs. Ability to manage multiple projects simultaneously. . Specialized Training: Experience/training in GCP, ICH, and/or FDA pharmaceutical regulations is beneficial.
Work Location NJ - Madison Relocation Available Yes
Status Full-Time
Associate Director, Clinical Affairs
Req #:
5368BR
Job Description:
Position Summary: Participate in pharmaceutical project development teams and facilitate regional and global clinical development. Accountable for expert ophthalmic contributions including the identification and evaluation of clinical scientific issues related to clinical trial implementation. Interpret clinical data and contribute to clinical study reports and related documentation required for pharmaceutical clinical development. Specific
Job Duties:
. Participate on pharmaceutical R&D teams as a clinical scientific representative. . Provide scientific expertise for pharmaceutical clinical development with respect to the planning and execution of clinical trials, including cross-functional collaboration and communication and global clinical scientific representation. . Provide input and oversight for all clinical scientific aspects of registrational trials including safety, tolerability and efficacy reporting. . Participate in global clinical development meetings, contribute to harmonized protocol designs, participate in and present clinical data during internal and external meetings and symposia. . Develop and maintain strong scientific relationships with medical experts in support of clinical development programs. . Manage all clinical scientific aspects of pharmaceutical clinical trials. . Ensure compliance with FDA regulations, GCP and ICH guidelines. . Identify and evaluate clinical scientific issues related to projects and implementation of sound resolutions. . Provide input on R&D departmental decisions related to processes and procedures.
Qualifications
Qualifications: .
Education:
MD or PhD required (MD, Ophthalmology preferred) . Experience: Minimum 5 years research, clinical trial or related experience. Must have excellent communication, organizational, and writing skills. .
Special Skills:
Experience with ophthalmic pharmaceuticals for the treatment of glaucoma and dry eye preferred. Demonstrated ability to train study personnel and study CRAs. Ability to manage multiple projects simultaneously. . Specialized Training: Experience/training in GCP, ICH, and/or FDA pharmaceutical regulations is beneficial.
Work Location NJ - Madison Relocation Available Yes
Status Full-Time
Nearest Major Market: New Jersey
Job Segments: Clinic, Healthcare, Management, Manager
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