Global Clinical Development Director — Lead & Innovate

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

Life insurance

Disability insurance

Tuition assistance

401(k) match

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products within a global health-care market.

This remote, full-time role leads cross-functional teams across medical affairs, regulatory, and vendors to advance GDCP initiatives. You will develop strategies for Phase I–IV trials, interpret results for regulatory submissions, and collaborate with internal and external stakeholders.

Qualifications

• MD or DO with clinical specialty; management experience preferred.
• Experience in pharmaceutical industry or translational clinical research with levels depending on role.
• Thorough knowledge of clinical medicine and science management.
• Excellent communication in meetings and in written/oral presentations; proficient with MS Office.
• Demonstrated leadership and ability to manage teams.
• Advanced understanding of drug development, regulatory filings, and health economics is a plus.
• Willingness to travel 30% domestically and internationally.

Responsibilities

• Design and oversee clinical research programs and protocols under GCP.
• Serve as internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and other teams, and to external regulatory agencies.
• Authors program strategies (GDCP) and oversees trials essential for safety, efficacy, and value.
• Interprets and communicates results of Phase I–IV investigations for NDA submissions.
• Oversees vendor and CRO relationships and provides clinical input to governance committees.
• Support regulatory filing activities and provide concise, clear argumentation in communications.

Skills

Accountability for Results

Strategic Thinking

Patient Centricity

Impactful Communication

Respectful Collaboration

Empowered Development

Education

MD/DO or equivalent

Tools

MS Office

Clinical trial management

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products within a global health-care market.

This remote, full-time role leads cross-functional teams across medical affairs, regulatory, and vendors to advance GDCP initiatives. You will develop strategies for Phase I–IV trials, interpret results for regulatory submissions, and collaborate with internal and external stakeholders.