Global Clinical Development Director - CNS & Digital Medicine

Texas Health Institute; Trenton (NJ); Hybrid; USD 180,000 - 300,000; Full time

Job summary

Otsuka Pharmaceutical Co. seeks a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products under GCP, focusing on CNS and Digital Medicine across development stages for a global market.

You will supervise trial strategies, ensure safety/effectiveness evaluation, and sign NDA submissions; collaborate with regulatory, medical affairs, and CROs to optimize development plans.

Qualifications

• MD or DO with clinical specialty (nephrology, immunology, or dermatology) and management experience.
• PhD/MPH/MBA a plus; exceptional cases with other clinical doctorates may be considered.
• 1–3 years in pharma or translational clinical research for Associate Director level; 3–6 years for Director; 6–9 years for Senior Director depending on experience.
• Strong knowledge of clinical medicine and science management; ability to deliver on time, on budget, and with quality.
• Excellent written and oral communication; proficient in MS Office.
• Experience leading, managing, and motivating teams; personnel management preferred.
• Advanced understanding of drug development with flexibility across therapeutic areas; knowledge of biostatistics, pharmacology, data management, medical writing; regulatory filings experience; health value creation concepts; willingness to travel 30% internationally.

Responsibilities

• Consults with patients' representatives and leaders to optimize trial objectives and protocols.
• Serves as internal medical/scientific consultant to cross-functional teams and external regulators.
• Authors program strategies and oversees trials for safety, efficacy, and value of products.
• Interprets and communicates Phase I–IV results for NDA submissions.
• Signatory on NDA submissions and clinical study documents.
• Involved in product life cycle management and seeking value-added innovations.
• Oversees vendor/CRO relationships and provides clinical input to governance.
• Supports regulatory filing activities and provides clear argumentation in communications.

Skills

Leadership

Strategic thinking

Communication skills

Team management

Travel availability

Education

MD/DO

PhD

MPH

MBA

Tools

Microsoft Office

Job description

Otsuka Pharmaceutical Co. seeks a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products under GCP, focusing on CNS and Digital Medicine across development stages for a global market.

You will supervise trial strategies, ensure safety/effectiveness evaluation, and sign NDA submissions; collaborate with regulatory, medical affairs, and CROs to optimize development plans.