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). Responsibilities Consult with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully apply their recommendations toward optimizing trial objectives, designs and protocols. Develop 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. Author program strategies (i.e., GDCP) and oversee trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates. Interpret and communicate results of Phase I–IV investigations in preparation for a new drug. Act as the signatory on NDA submissions and clinical study and safety documents. Involve in product life‑cycle management from the earliest stages of development, constantly seeking innovations to add value strategically. Provide strategic oversight in vendor and CRO relationships, and provide clinical input into their governance committees. Help lead and support regulatory filing activities and documents. Provide strategic direction and editing to produce concise, clear and convincing argumentation in all written and verbal communications. Qualifications Basic – 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. Preferred – 6+ years of experience in the pharmaceutical industry or in academic translational clinical research, depending on type of experience at application. Thorough knowledge of clinical medicine and science management. Ability to communicate effectively in meetings and via written and oral presentations. Facility with Microsoft Suite (Word, Excel, PowerPoint, Outlook). Demonstrated experience leading, managing and motivating team members. Prior personnel management experience is a plus. Advanced understanding of drug development principles and clinical trial implementation, management and reporting. Flexibility across therapeutic areas and stages of clinical development. Working knowledge of biostatistics, clinical pharmacology, formulation science, data management, and medical writing. Complete understanding of global regulatory requirements. Successful regulatory filing experience is an advantage. Knowledge of health value creation principles, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies. Dedication to assigned projects and goals, including collaborative teamwork in a regulated environment. Willingness to travel 30% of the time, over weekends and 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 & 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. Salary: Minimum $209,599.00 – Maximum $313,375.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. Benefits Comprehensive medical, dental, vision, prescription drug coverage; company‑provided basic life, accidental death & dismemberment, short‑term and long‑term disability insurance; tuition reimbursement; student loan assistance; generous 401(k) match; flexible time off; paid holidays; paid leave programs; and other company‑provided benefits. Equal Opportunity Employer 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. You can request reasonable accommodations by contacting Accommodation Request. #J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd