DIRECTOR, Pharmaceutical and Clinical Affairs - (US-NY-Rochester)
DIRECTOR, Pharmaceutical and Clinical Affairs - (US-NY-Rochester)
Compensation: $120K - $150K / Year
Minimum Education: Doctorate
Job Type: Full Time
Jobcode: B4074
Experience Required : 3 - 5 years
Degree Required : MD
Travel Required : to 25% :
� The DIRECTOR, PHARMACEUTICAL CLINICAL & SCIENTIFIC AFFAIRS is responsible for the development of products in the Rx, OTC, Generics and Nutraceuticals categories
� Leads a group of scientists (MDs and ODs) responsible for clinical trial design, scientific evaluations during the conduct of the trials (monitoring of safety, eligibility, enrollment and data consistency) and analysis of results
� Accountable for product clinical development programs that are of high quality but also lead to timely and cost-effective regulatory approval
� Serves as the leader of the Pharmaceutical Global Clinical Development matrixed team in the planning and executions of clinical trials. The team includes operations, statistics, data management, and Medical writing in addition to scientists
� Collaborates and takes clinical leadership role within cross-functional teams including project managers, preclinical, regulatory, clinical trial materials etc.
� Responsible for the clinical aspects of clinical study reports and responses to regulatory authorities
� Contributes to abstract/manuscript/presentation writing/review for scientific meetings and internal management reviews
� Maintains responsibility for the clinical input into Business Development due diligences
� Provides medical expertise and medical evaluation of questions regarding ophthalmology clinical practice
� Develops/maintains relationships with external experts who might be needed to support clinical development programs
� Provides scientific and clinical research expertise in the development of overall strategy of the Pharmaceutical business and more specific product clinical development plan
� Performs management functions as goal setting, individual development plans and performance evaluations of staff. Identifies training needs to staff and implements training plan
� Proactively evaluates and contributes to process improvement
Candidate Must Have :
* Medical Degree from an accredited US or foreign medical school AND exp in ophthamology
* At least 5 years of total experience post medical training, including clinical practice AND industry experience in the planning, execution and reporting of clinical trials.
* Strong understanding of GCP, ICH, and regulatory compliance
* Knowledge of scientific methods, research design, and medical practices and procedures in ophthalmology
Email resume in Word to thebiggamehunter@cisny.com. Please include the job code for the position with your resume.
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posted by Unknown at 2:06 PM
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