Global Clinical Development Director — Remote

Otsuka America Pharmaceutical Inc.; Hartford (CT); Remote; USD 210,000 - 313,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Global Clinical Development to design and oversee clinical research programs for OPDC products.

The role can be remote or located in Princeton, NJ, or Rockville, MD, with responsibilities spanning Rheumatology, Immunology and Specialty Medicine in a global market. You will consult with diverse stakeholders, author program strategies, and provide strategic oversight of CROs and regulatory filings.

Qualifications

• A clinician with MD or DO and management experience (direct or indirect).
• 3–6 years in pharma or translational clinical research.
• Thorough knowledge of clinical medicine and science management.
• Effective communication in meetings and presentations; proficient with MS Office.
• Demonstrated leadership experience with teams or investigators.
• Advanced understanding of drug development principles and clinical trial implementation.
• Flexibility across therapeutic areas and stages of development.
• Working knowledge of biostatistics, clinical pharmacology, data management, and medical writing.
• Understanding of global regulatory requirements and potential for regulatory filings.
• Knowledge of health value creation, including financial assessment and project budgeting.
• Willingness to travel 30% +/-; ability to travel internationally.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products.
• Consults with patients, clinicians, regulatory and scientific leaders to optimize trial objectives.
• Acts as internal medical/scientific consultant to cross-functional teams and external agencies.
• Authors program strategies and oversees trials to determine safety, efficacy and value.
• Interprets Phase I–IV results for NDA submissions and regulatory communications.
• Provides strategic oversight of vendor and CRO relationships.
• Leads regulatory filing activities and edits communications for clarity and impact.
• Contributes to product life cycle management with strategic value enhancements.

Skills

Clinical expertise

Regulatory knowledge

Leadership

GCP knowledge

Communication

Education

MD/DO

Additional degrees (PhD/MPH/MBA)

Other clinical doctorates considered

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Global Clinical Development to design and oversee clinical research programs for OPDC products.

The role can be remote or located in Princeton, NJ, or Rockville, MD, with responsibilities spanning Rheumatology, Immunology and Specialty Medicine in a global market. You will consult with diverse stakeholders, author program strategies, and provide strategic oversight of CROs and regulatory filings.