Senior Director, Global Clinical Development CNS- Psychiatry - Lifelancer

Job Description

• - 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 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:
• -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 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 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. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/4a14529ea6787c5b36acd419fd748db2