Senior Director, Global Clinical Development & Strategy

Otsuka; United States; Remoto; USD 250.000 - 388.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive medical, dental, vision

401(k) match

Tuition reimbursement

Descrizione del lavoro

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC-GCD) is seeking a physician leader to direct global clinical development programs.

The role emphasizes strategic oversight, regulatory submissions, and cross-functional collaboration across health economics, medical affairs, regulatory, and clinical operations. Ideal candidates will possess MD/DO with 6–9 years in translational clinical research, strong leadership, and travel willingness (≈30%).

Competenze

• Physician with MD/DO, psychiatry/neurology preferred; advanced degrees are a plus.
• 6–9 years pharma/academic translational clinical research experience for senior director level.
• Strong clinical medicine and science management with focus on business outcomes.
• Excellent oral and written communication; proficient with Word, Excel, PowerPoint, Outlook.
• Experience leading and motivating teams; prior personnel management helps at senior levels.
• Deep understanding of drug development and clinical trials; flexible across therapeutic areas.
• Knowledge of biostatistics, pharmacology, data management, and medical writing.
• Understanding of global regulatory requirements; prior filings advantageous.
• Willingness to travel ~30% including international travel.

Mansioni

• Consult with patients and internal leaders to optimize trial objectives and protocols.
• Act as internal medical/scientific consultant to health economics, medical affairs, marketing, regulatory, statistics, and other teams.
• Authors program strategies and oversees trials for determining safety, efficacy and value.
• Interpret Phase I–IV results for NDA submissions and regulatory decisions.
• Sign NDA submissions and clinical study documents.
• Provide strategic oversight of vendor and CRO relationships and governance.
• Lead regulatory filings and provide clear written/verbal communications.
• Guide projects to align with corporate goals and timelines.

Conoscenze

Leadership experience

Communication skills

Drug development knowledge

Regulatory understanding

Team management

Travel willingness

Formazione

MD or DO

Advanced degrees (PhD/MPH/MBA)

Clinical research background

Strumenti

Microsoft Office Suite

Regulatory submissions

Descrizione del lavoro

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC-GCD) is seeking a physician leader to direct global clinical development programs.

The role emphasizes strategic oversight, regulatory submissions, and cross-functional collaboration across health economics, medical affairs, regulatory, and clinical operations. Ideal candidates will possess MD/DO with 6–9 years in translational clinical research, strong leadership, and travel willingness (≈30%).