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 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. 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 https://www.otsuka-us.com/careers-join-otsuka . 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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development
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