Director, Global Clinical Development

Otsuka Pharmaceutical Companies (U.S.)

Otsuka clinical development director overseeing global drug research programs for rare diseases. Guiding trials, regulatory filings, and product life-cycle strategy for worldwide healthcare markets.

Posted 8/18/2026full-timeRemote • Maryland, New Jersey • 🇺🇸 United StatesLead💰 $209,599 - $313,375 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research program design and oversight, with a strong focus on drug development principles and regulatory compliance. Proven ability to lead cross-functional teams and communicate effectively with diverse stakeholders in the pharmaceutical industry.

Highest-signal resume keywords

M.D. Or D.O. QualificationClinical Research ExperienceDrug Development PrinciplesRegulatory Filing ActivitiesClinical Trial Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research DesignClinical Trial ImplementationData ManagementMedical WritingBiostatisticsImmunology KnowledgeFormulation SciencePharmaceutical Industry ExperiencePhase I–IV Clinical ActivitiesSafety And Efficacy Assessment

Soft Skills

Effective CommunicationLeadershipTeam ManagementStrategic OversightMotivating Staff

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

GCPRare DiseasesInherited Metabolic DiseasesSpecialty MedicineNDA SubmissionsHealth Economic ConsultingClinical GovernanceProduct Life-Cycle ManagementGlobal Regulatory RequirementsClinical Protocols

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Design and oversee clinical research programs and protocols for OPDC products under GCP
Evaluate and support clinical development of Rare Diseases, Inherited Metabolic Diseases, and Specialty Medicine products at different development stages
Consult with patients or representatives and clinical, regulatory, and scientific leaders to optimize trial objectives, designs, and protocols
Serve as a clinical/medical scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and research project teams and external regulatory agencies
Author program strategies such as GDCP and oversee trials assessing safety, efficacy, medical usefulness, and product value
Interpret and communicate Phase I–IV investigation results for new drug preparation
Act as signatory on NDA submissions and clinical study and safety documents
Contribute to product life-cycle management and identify strategic innovations
Provide strategic oversight of vendor and CRO relationships and clinical input to governance committees
Lead and support regulatory filing activities and documents
Provide strategic direction and editing for concise, clear, and convincing written and verbal communications

Requirements

What you’ll need

Required clinician qualification: M.D. or D.O., preferably a geneticist, metabolic physician, rare disease expert, or immunology specialist
Highly qualified candidates with other clinical/scientific doctorates may be considered when complemented by a team or consulting clinician
3–6 years of pharmaceutical industry, clinical practice, or academic translational clinical research experience is typically required for Director level, depending on experience type
At least 5 years of involvement in clinical research or drug development in an academic or industry environment
Experience across clinical activities in Phases I through IV
Thorough knowledge of clinical medicine and science management
Ability to define critical objectives and deliver business outcomes on time, on budget, and with superior quality
Ability to communicate effectively in meetings and written and oral presentations
Facility with Microsoft Word, Excel, PowerPoint, and Outlook
Demonstrated experience leading, managing, and motivating internal staff and external investigators or consultants
Advanced understanding of drug development principles and clinical trial implementation, management, and reporting
Flexibility working across different therapeutic areas and stages of clinical development
Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing
Complete understanding of global regulatory requirements

Benefits

Comp & perks

Incentive opportunity
Comprehensive medical coverage
Dental coverage
Vision coverage
Prescription drug coverage
Company-provided basic life insurance
Accidental death & dismemberment insurance
Short-term disability insurance
Long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company-provided benefits