Senior Director, Global Clinical Development

Otsuka Pharmaceutical Companies (U.S.)

. Lead clinical development strategy and execution for assigned programs from proof of concept through late-stage trials and regulatory submissions .

Posted 10/14/2026full-timeRemote • United StatesSenior💰 $230,720 - $345,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical development strategy, regulatory compliance, and medical leadership across various therapeutic areas. Proven ability to manage clinical trials, mentor teams, and collaborate with regulatory affairs and external partners.

Highest-signal resume keywords

M.D. Or D.O.Clinical Research ExperienceRegulatory ComplianceClinical Trial ManagementMedical Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial DesignData InterpretationBiostatisticsMedical WritingDrug Development PrinciplesClinical PharmacologyImmunology KnowledgeVendor ManagementINDs And NDAsPublication Planning

Soft Skills

Strong Communication SkillsLeadershipMentoringTeam MotivationPresentation Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

Good Clinical PracticeGlobal Regulatory RequirementsPharmaceutical IndustryClinical PracticeTranslational Clinical Research

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead clinical development strategy and execution for assigned programs from proof of concept through late-stage trials and regulatory submissions
Provide medical and scientific leadership to cross-functional study teams
Ensure high-quality clinical trial design, conduct, and data interpretation
Serve as medical lead and subject matter expert for assigned indications
Ensure trials comply with GCP, regulatory requirements, and internal processes
Lead and contribute to clinical sections of INDs, IBs, clinical study reports, and NDAs/BLAs
Collaborate with regulatory affairs on interactions with global health authorities
Provide strategic and medical oversight to vendor and CRO relationships and governance committees
Lead clinical discussions with KOLs and advisory boards
Develop medical monitoring plans and asset development plans
Contribute to publication plans and review scientific manuscripts
Mentor and provide leadership to junior team members
Support business development through medical due diligence and evaluation of external opportunities
Contribute to corporate continuous process improvement initiatives

Requirements

What you’ll need

M.D. or D.O., preferably with an immunology, rheumatology, or dermatology background
Management experience, direct or indirect
Minimum of five years of clinical research experience post academia as a general guideline
Experience in the pharmaceutical industry, clinical practice, and/or academic translational clinical research
Thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines, including biostatistics, data management, and medical writing
Advanced understanding of clinical medicine and science
Advanced understanding of drug development principles and clinical trial implementation and management
Complete understanding of global regulatory requirements
Working knowledge of marketing and commercialization
Understanding of corporate goals and basic business principles
Demonstrated experience across developmental phases, including preclinical or in-licensing evaluation, early clinical safety and proof of concept, global registration trials, and late-stage life-cycle management
Demonstrated experience leading clinical aspects of regulatory interactions
Ability to work across therapeutic areas and stages of clinical development
Demonstrated ability to manage and motivate clinical team members, internal staff, and external investigators/consultants
Strong communication and presentation skills
Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook
Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing
Travel approximately 30–35%

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