Director, Global Clinical Development (Remote)

Sacbar; Princeton (NJ); Remote; USD 180,000 - 250,000; Full time

Job summary

Otsuka is seeking a Director, Global Clinical Development (GCD) to lead the design and oversight of clinical research programs across rheumatology, immunology and specialty medicine.

The role allows for remote work or in-office placement in Princeton, NJ or Rockville, MD, with travel to support global development initiatives and regulatory filings in a rapidly evolving healthcare market.

Qualifications

• A clinician (M.D., or D.O.) preferably a rheumatology, nephrology or immunology background, including prior management experience.
• 3-6 years of experience in the pharmaceutical industry or in academic translational clinical research.
• A thorough knowledge of clinical medicine and science management with focus on business outcomes.
• Effective communication in meetings and presentations; proficient in Microsoft Office.
• Demonstrated experience leading, managing and motivating team members.
• Advanced understanding of drug development principles and clinical trial implementation.
• Flexibility across therapeutic areas and stages of development.
• Knowledge of biostatistics, clinical pharmacology, formulation science, data management and medical writing.
• Understanding of global regulatory requirements; experience with regulatory filings is an advantage.
• Knowledge of health value creation including financial assessment, budgeting, market research.
• Dedication to project goals and matrixed teamwork in a regulated setting.
• Willingness to travel 30% of time, including international travel.

Responsibilities

• Consults with patients or their representatives, clinical, regulatory and scientific leaders to optimize trial objectives and designs.
• Serves as internal medical/scientific consultant to health economics, medical affairs, marketing, regulatory, statistics and other teams.
• Authors program strategies and oversees trials essential for determining safety, efficacy and value of product candidates.
• Interprets and communicates results of Phase I–IV investigations for regulatory submissions.
• Acts as signatory on NDA submissions and clinical study and safety documents.
• Provides strategic oversight of vendor and CRO relationships and governance input.
• Leads regulatory filing activities and edits communications to ensure concise, convincing arguments.

Skills

Leadership

Team management

Strategic thinking

Regulatory filing

Project planning

Budgeting

Communication

Medical writing

Cross-functional collaboration

Clinical development

Education

MD/DO

PhD/MPH/MBA a plus

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Otsuka is seeking a Director, Global Clinical Development (GCD) to lead the design and oversight of clinical research programs across rheumatology, immunology and specialty medicine.

The role allows for remote work or in-office placement in Princeton, NJ or Rockville, MD, with travel to support global development initiatives and regulatory filings in a rapidly evolving healthcare market.