Director, Global Clinical Development

Otsuka Pharmaceutical Companies (U.S.)

Associate Director/Director/Senior Director of Global Clinical Development at Otsuka. Overseeing clinical research programs and protocols for CNS and Digital Medicine products.

Posted 7/30/2026full-timeMaryland, 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, regulatory filing activities, and drug development principles, with a strong focus on CNS and Digital Medicine products. Proven ability to lead teams, communicate effectively, and manage vendor relationships while ensuring compliance with global regulatory requirements.

Highest-signal resume keywords

M.D. Or D.O. DegreeClinical Research Program DesignRegulatory Filing ExperienceDrug Development PrinciplesTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ImplementationClinical Medicine KnowledgeBiostatisticsClinical PharmacologyFormulation ScienceData ManagementMedical WritingHealth Value CreationProject PlanningNDA Submission

Soft Skills

Effective CommunicationTeam ManagementMotivating Team MembersFlexibility

Certifications & Qualifications

Ph.D.M.P.H.M.B.A.

Industry Keywords

CNS ProductsDigital MedicinePharmaceutical IndustryTranslational Clinical ResearchGlobal Regulatory Requirements

About the role

Key responsibilities & impact

Design and oversee clinical research programs and protocols for OPDC products
Evaluate and clinically develop CNS and Digital Medicine products
Consult with patients or their representatives, clinical, regulatory, and scientific leaders
Develop program strategies (i.e., GDCP) and oversee trials
Interpret and communicate results of Phase I-IV investigations
Act as the signatory on NDA submissions and clinical study documents
Involved in product life cycle management and seek innovations
Provide strategic oversight in vendor and CRO relationships
Lead and support regulatory filing activities

Requirements

What you’ll need

A clinician (M.D., or D.O.), preferably a psychiatrist or neurologist
Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus
6+ years of experience in the pharmaceutical industry or in academic translational clinical research
Thorough knowledge of clinical medicine and science management
Ability to communicate effectively in meetings and via written and oral presentations
Experience leading, managing, and motivating team members
Advanced understanding of drug development principles and clinical trial implementation
Flexibility in working across different therapeutic areas
Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing
Complete understanding of global regulatory requirements
Demonstrated experience in successful regulatory filings
Understanding of health value creation, including financial assessment and project planning
Willingness to travel 30% of time, including weekends and internationally

Benefits

Comp & perks

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
Other company provided benefits