Director, Global Clinical Development

Responsibilities

• Design and oversee clinical research programs and protocols for OPDC products under GCP.
• Evaluate and develop Rheumatology, Immunology and Specialty Medicine products across global markets.
• Consult with patients, clinical, regulatory and scientific leaders to optimize trial objectives, designs, and protocols.
• Serve as internal medical/scientific consultant to cross‑functional teams and external regulators.
• Author program strategies and oversee trials essential for determining clinical safety, efficacy, and value.
• Interpret and communicate results of Phase I–IV investigations for drug development.
• Act as signatory on NDA submissions and clinical study and safety documents.
• Participate in product life cycle management from early stages, innovating for strategic value.
• Provide strategic oversight of vendor and CRO relationships, including governance committee input.
• Lead and support regulatory filing activities, providing clear and convincing argumentation in written and verbal communications.

• Clinician (M.D. or D.O.), preferably psychiatrist or neurologist, with prior management experience; supplementary degrees (Ph.D., M.P.H., M.B.A.) are a plus.
• Pharmaceutical industry or academic translational clinical research experience: 1–3 years (Associate Director); 3–6 years (Director); 6–9 years (Senior Director).
• Thorough knowledge of clinical medicine and science management, defining objectives and maintaining focus on business outcomes.
• Effective communication skills in meetings and written presentations; proficiency in Microsoft Word, Excel, PowerPoint, Outlook.
• Experience leading, managing and motivating team members; prior personnel management experience is supportive.
• Advanced understanding of drug development principles, clinical trial implementation, management and reporting, including flexibility across therapeutic areas and development stages.
• Working knowledge of biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
• Complete understanding of global regulatory requirements; experience in regulatory filings is an advantage.
• Knowledge of health value creation principles: financial assessment, project planning, budgeting, market research, commercialization strategies.
• Dedication to assigned projects and achievement of corporate goals through matrixed teamwork in a regulated environment.
• Willingness to travel up to 30%, including weekends and international travel.

• Accountability for Results: Stay focused on key strategic objectives and lead change initiatives.
• Strategic Thinking & Problem Solving: Make decisions considering long‑term impact.
• Patient & Customer Centricity: Focus on the needs of customers and stakeholders.
• Impactful Communication: Communicate with clarity, logic, and respect; influence at all levels.
• Respectful
  
  Collaboration:
  
  Value diverse perspectives and form partnerships toward common goals.
• Empowered Development: Actively pursue professional development as a business imperative.

Minimum $ – Maximum $, plus incentive opportunity; typical pay ranges for U.S. incumbents. Actual pay determined by experience, skills, and internal comparisons.

Posted for a minimum of 5 business days.

Comprehensive medical, dental, vision, prescription drug coverage; life insurance, accidental death & dismemberment, short‑/long‑term disability insurance; tuition reimbursement; student loan assistance; generous 401(k) match; flexible time off; paid holidays and leave.

This job description is intended to describe the general nature and level of the work performed by the position. It is not intended to include every job duty and responsibility. Otsuka reserves the right to amend and change responsibilities as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation. Contact Accommodation Request at E