Remote Global Clinical Development Leader

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

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a Director, Global Clinical Development to oversee global CNS and digital medicine trials, ensuring GCP compliance and strategic alignment with GDCP.

You will lead cross-functional teams, interact with regulators, health economists, and CROs, and sign NDA submissions while shaping product development from early to post-approval. This remote, full-time role requires 30% travel.

Qualifications

• Clinician with MD or DO degree; management experience preferred.
• Experience in pharmaceutical industry or translational clinical research.
• Strong communication and presentation skills; capable of leading teams.

Responsibilities

• Designs and oversees clinical research programs and protocols.
• Serves as internal medical/scientific consultant to cross-functional teams and external regulators.
• Authors program strategies (GDCP) and oversees pivotal trials.
• Interprets Phase I–IV results for NDA submissions and regulatory discussions.
• Leads regulatory filings and contributes to life-cycle management.
• Oversees vendor and CRO relationships and provides clinical input to governance committees.

Skills

MD/DO clinician

Nephrology

Immunology

Leadership

GCP knowledge

Education

MD/DO (plus PhD/MPH/MBA desirable)

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical, Inc. is seeking a Director, Global Clinical Development to oversee global CNS and digital medicine trials, ensuring GCP compliance and strategic alignment with GDCP.

You will lead cross-functional teams, interact with regulators, health economists, and CROs, and sign NDA submissions while shaping product development from early to post-approval. This remote, full-time role requires 30% travel.