Director, Global Clinical Development

Job Description

• Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department.
• OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products.
• Our team is collaborative, innovative with a mantra of “acting as though the company was our own.”
• Our responsibilities range from due-diligence evaluations, where we stress-test others’ development plans, to development and implementation of our own global development & commercialization plans (GDCP).
• The GDCP translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials.
• Its goal is to efficiently evaluate the product’s potential and probability of success, support an effective commercial launch and plan for meaningful innovations to improve or expand the value of the initial product for our global customers (patients, prescribers and payors).

Detailed Description of Duties

• Otsuka is seeking a Director, Global Clinical Development 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 CNS and Digital Medicine products at different stages of development for a global health-care market. The specific duties assigned to the r 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 an internal medical/scientific consultant to health economic, medical affairs, marketing, regul