Director Clinical Development
Location : Park Ridge NJ US 07656
Job Type : Direct
Reference Code : 19919-AB1
Compensation : 180000.00 - 220000.00 USD/YEAR
Start Date : 08/13/2019
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a Director of Clinical Development Development to serve as a scientific & operational lead of assigned clinical studies to ensure proper planning, execution, completion, and reporting in accordance with all applicable regulatory requirements and in compliance with SOPs and GCP/ICH guidelines.
- Write or contribute to the development of study protocols, informed consent forms, study reports, annual reports, & other clinical and regulatory documents.
- Lead the process of selection of CRO and other external service providers.
- Provide leadership and guidance to CRO/external service providers in their day-to-day operational activities to ensure compliance with study protocol and in accordance with agreed scope of work.
- Work with CRO to help identify, select, and monitor performance of investigational sites for clinical studies, review reports from CRO for all site interaction visits, and identify areas of concern and escalate to Supervisor in a timely manner.
- Responsible for review and approval of investigational product (IP) release packages and management of IP accountability and reconciliation process with the CRO.
- Responsible for professional, ethical, and timely interactions with investigators, advisors, site staff, and study team members to ensure smooth communication and interaction within study/project team.
- Review study data on an ongoing basis to ensure accuracy and integrity, review and assist in appropriate closing of data queries to ensure timely database lock.
- Responsible for working with CRO to ensure completeness of Trial Master File on an ongoing basis.
Required Qualifications :
- Bachelor's degree is required, preferably in a science related field. Advanced degree (MS, PharmD, or PhD is preferred).
- Minimum 5 years of clinical development experience in pharmaceutical industry.
- Experience in conducting Oncology or Acute Care studies is preferred.
- In-depth knowledge of regulatory requirements and GCP/ICH guidelines is required.
- Strong attention to detail and ability to work independently and in collaboration within a cross-functional team environment is required.
- Ability to work efficiently in a fast-paced work environment is required.
- Strong oral (including presentation) and written communication, project management, and computer (MS Project, Word, Excel, PowerPoint, Outlook, etc) skills are required.
Contact: Allan Berman
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