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 Otsukas 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 products 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, 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, 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 neurologist 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 (1-3 years for Associate Director level; 3-6 years for Director).
A thorough knowledge of clinical medicine and science management. This entails defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality.
An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Demonstrated experience leading, managing and motivating team members (e.g., internal staff and external investigators or consultants). While not essential, prior personnel management experience, will support position at entry (Associate Director/Director/Senior Director).
An advanced understanding of drug development principles and clinical trial implementation, management and reporting is essential and will be further developed, including:
Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies.
Dedication to assigned, developed projects and project goals. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.
Willingness to travel 30% of time, over weekends and ability to travel internationally.
At Otsuka, we defy limitation, so that others can too.
We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.
Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.