[Remote] Director, Global Clinical Development

Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Development and Commercialization is a leading company in the pharmaceutical industry, and they are seeking a Director of Global Clinical Development. The role involves designing and overseeing clinical research programs and protocols for CNS and Digital Medicine products, ensuring compliance with good clinical practices while engaging with various stakeholders to optimize trial objectives.ResponsibilitiesConsults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocolsDevelops 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 agenciesAuthors 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 candidatesInterprets and communicates results of Phase I-IV investigations in preparation for a new drugActs as the signatory on NDA submissions and clinical study and safety documentsInvolved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategicallyProvides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committeesWill 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 communicationsSkillsA 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 clinicianExperience 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 qualityAn 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 developmentWorking knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writingComplete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantageWorking knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategiesDedication 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 settingWillingness to travel 30% of time, over weekends and ability to travel internationallyBenefitsComprehensive medical, dental, vision, prescription drug coverageCompany provided basic lifeAccidental death & dismembermentShort-term and long-term disability insuranceTuition reimbursementStudent loan assistanceA generous 401(k) matchFlexible time offPaid holidaysPaid leave programsOther company provided benefitsCompany OverviewThere are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc. It was founded in 1989, and is headquartered in Rockville, Maryland, USA, with a workforce of 1001-5000 employees. Its website is https://www.otsuka-us.com.Company H1B SponsorshipOtsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships, with 2 in 2026, 8 in 2025, 6 in 2024, 11 in 2023, 5 in 2022, 9 in 2021, 13 in 2020. Please note that this does not guarantee sponsorship for this specific role.