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Senior Director, Global Clinical Development – Psychiatry and Neurology
Otsuka Pharmaceutical Companies (U.S.). Design and oversee clinical research programs and protocols for OPDC products under good clinical practices (GCP) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research program design and oversight, with a strong foundation in drug development principles and regulatory requirements. Proven ability to lead cross-functional teams and communicate effectively with diverse stakeholders in a global healthcare environment.
Highest-signal resume keywords
M.D. Or D.O.Clinical Research Program DesignDrug Development PrinciplesRegulatory RequirementsClinical Trial Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Medicine KnowledgeBiostatisticsClinical PharmacologyFormulation ScienceData ManagementMedical WritingProject PlanningBudgetingMarket ResearchCommercialization Strategies
Soft Skills
Effective CommunicationLeadershipMotivating TeamsFlexibilityDedication
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook
Industry Keywords
Good Clinical PracticesCNS ProductsDigital MedicineVendor RelationshipsCRO RelationshipsClinical SafetyEfficacy AssessmentNDA SubmissionsGlobal Healthcare MarketHealth Value Creation
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Design and oversee clinical research programs and protocols for OPDC products under good clinical practices (GCP)
- Evaluate and clinically develop CNS and Digital Medicine products at different development stages for a global healthcare market
- Consult with patients or representatives, clinical, regulatory, and scientific leaders to optimize trial objectives, designs, development plans, and protocols
- Serve as an internal medical/scientific consultant to health economics, medical affairs, marketing, regulatory, statistical, and research project teams, as well as external regulatory agencies
- Author global development and commercialization plans, protocols, and study reports
- Oversee trials assessing clinical safety, efficacy, medical usefulness, and product value
- Interpret and communicate Phase I–IV investigation results in preparation for new drug submissions
- Act as signatory on NDA submissions and clinical study and safety documents
- Contribute to product lifecycle 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, providing strategic direction and editing
- Collaborate across a matrixed organization to achieve clinical development and business objectives
Requirements
What you’ll need- M.D. or D.O.; preferably a psychiatrist or neurologist
- Prior management experience, direct or indirect
- 6–9 years of experience in the pharmaceutical industry or academic translational clinical research for Senior Director levels, depending on experience type
- Thorough knowledge of clinical medicine and science management
- Ability to communicate effectively in meetings and via written and oral presentations
- Facility with Microsoft Word, Excel, PowerPoint, and Outlook
- Demonstrated experience leading, managing, and motivating internal staff, external investigators, or consultants
- Advanced understanding of drug development principles and clinical trial implementation, management, and reporting
- Flexibility to work across different therapeutic areas and clinical development stages
- Working knowledge of biostatistics, clinical pharmacology, formulation science, data management, and medical writing
- Complete understanding of global regulatory requirements
- Working knowledge of health value creation, including financial assessment, project planning and budgeting, market research, and commercialization strategies
- Dedication to assigned projects and project goals in a compliant, regulated, matrixed business setting
- Willingness to travel 30% of the time, including weekends, and ability to travel internationally
Benefits
Comp & perks- Comprehensive medical, dental, vision, and prescription drug coverage
- Company-provided basic life insurance
- Accidental death and dismemberment insurance
- 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
- Incentive opportunity