Director, Global Clinical Development

Otsuka is seeking an Director, Global Clinical Development (GCD) based remotely or in our Princeton, NJ or Rockville, MD offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).

The incumbent will be responsible for the evaluation and clinical development of Rare Diseases, or Inherited Metabolic Diseases and Specialty Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Director, Global Clinical Development include the following:

• Consults with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.
• Develops focused expertise to serve as a clinical/medical scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.
• Authors program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.
• Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.
• Acts as the signatory on NDA submissions and clinical study and safety documents.
• Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.
• Provides strategic oversight in our vendor and CRO relationships and provides clinical input into their governance committees.
• Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear, and convincing argumentation in all such written and verbal communications.

Qualifications

Required

* A clinician (M.D., or D.O.) preferably a geneticis