Director, Global Clinical Development

- 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).

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, 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.

• A clinician (M.D., or D.O.) preferably a nephrologist, immunologist or dermatologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.
  
  D., Psy.
  
  D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
• Experience in the pharmaceutical industry or in academic translational clinical research (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 years for Senior Director levels is typically required depending on type of experience at application).
• A thorough knowledge of clinical medicine and science management. This entails defining critical…