[Remote] Senior Director, Global Clinical Development – Nephrology & Immunology

Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Companies (U.S.) is seeking an experienced and visionary Senior Director, Global Clinical Development with expertise in immunology. The successful candidate will lead the clinical development strategy across multiple programs, ensuring high standards of scientific and medical integrity while overseeing clinical research programs and protocols.ResponsibilitiesLead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissionsProvide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretationServe as the medical lead and subject matter expert for assigned indicationsPartner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processesLead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAsCollaborate with regulatory affairs on interactions with global health authoritiesProvides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committeesLead clinical discussions with KOLs and advisory boardsDevelop clinical documents including medical monitoring plans, asset development plansContribute to development of publication plans and review scientific manuscripts for publicationsMentor and provide leadership to junior team members within the organizationSupport business development activities through medical due diligence and evaluation of external opportunitiesContributes to corporate initiatives by participating in continuous process improvement to meet companySkillsA clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including 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, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia)Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)An advanced understanding of clinical medicine and scienceAdvanced understanding of drug development principles and clinical trial implementation and managementComplete understanding of the global regulatory requirementsWorking knowledge of marketing and commercializationComplete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business settingDemonstrated experience in all developmental phases including evaluation of pre-clinical or in licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late stage life-cycle management strategiesDemonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plusAbility to work across different therapeutic areas and different stages of clinical developmentDemonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants)Strong communication and presentation skillsStrong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)Knows how/when to apply organizational policy or procedures to a variety of situationsAn advanced understanding of drug development principles and clinical trial implementation, management and reporting are 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 immunology, 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 advantageBenefitsComprehensive 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.