Senior Director, Global Clinical Development CNS

Job Description

• Description of our Company, Responsibilities, Duties and Required Qualifications Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.”
• - Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs as well as nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.  
• - Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (9.9 billion) in 2016.  
• - All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.  
• - 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 an Associate Director/Director/Senior Director, Global Clinical Development based in our Rockville, MD or Princeton, NJ 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 CNS and Digital Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Associate Director/Director/Senior 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.
• Detailed Description of Required Qualifications:
• - A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management e