Associate Director, Clinical R &D
American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectable pharmaceutical drugs for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
The position of Associate Director within Clinical Research and Development (R&D) is primarily responsible for contribution to and support of the Injectafer clinical development program for heart failure. Additional responsibilities entail contribution to the Clinical R&D unit’s activities and departmental support as assigned.
Essential Duties and Responsibilities
- Strategic support to the Medical Director for study execution, data integrity, medical oversight, and vendor management.
- Provision of scientific and clinical leadership, guidance, and perspective to matrix teams including Regulatory Affairs, Clinical Quality Assurance, and Medical Affairs.
- Contribute to the development of ICH Common Technical Documents such as clinical study reports and supplemental FDA submission documents.
- Management, review, and approval of the ongoing clinical study and sub study, as assigned, inclusive of case report forms, guideline assessments, study reports, and data dissemination plans.
- Provision of ongoing protocol and/or therapeutic area training for the internal and external project teams.
- Assistance in investigator site performance assessments and assurances of study participant retention.
- Assurance of subject safety, study monitoring and adequate reporting of clinical events. .
- Oversee the generation of Medical Monitoring and Safety Plans.
- Ensure timely updates to protocol amendments, Investigators Brochures, and product labels as required.
- Participation in and/or presents at Investigator Meetings and national data dissemination meetings.
- Interactions with Contract Research Organizations (CROs), healthcare consultants, and investigators.
- Oversee and participate in clinical study report writing, critical medical or scientific review, and assessment of written documents.
- As assigned, supportive coverage to the Pharmacovigilance unit for medical case monitoring and aggregate trend reporting for Injectafer clinical studies and safety reports.
Education Requirements and Qualifications
- Medical (M.D., D.O.) degree with subspecialty training, required.
- United States (US) medical license, strongly preferred.
- At least 4 years’ experience in clinical care of patients, required.
- At least 4 years of pharmaceutical business development, academic research, or a clinical research organization (CRO), with evidence of successful ongoing career development, required.
- Excellent oral and written communication skills.
- Ability to make decisions independently and with appropriate input.
- Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, Medical Affairs, and Business Development.
- Software: MS Office with emphasis on Word, Excel, Power Point.
- Domestic and International travel might be required.
- Must be able to read documents such as Standard Operating Procedures, Clinical documents and other technical documents.