Director, Global Clinical Development

Job Overview

APC-GCD (Otsuka Pharmaceutical Development & Commercialization, Inc.) is hiring an Associate Director/Director/Senior Director for Global Clinical Development in Rockville, MD or Princeton, NJ. The role will design and oversee clinical research programs and protocols for OPDC products under Good Clinical Practices (GCP), focusing on CNS and Digital Medicine products across multiple development stages for the global health‑care market.

• Consult with patients or their representatives, clinical, regulatory, and scientific leaders to optimize trial objectives, designs, and protocols.
• Serve as an internal medical/scientific consultant to health‑economic, medical affairs, marketing, regulatory, statistical, and other research team members, and to external regulatory agencies.
• Author program strategies (e.g., GDCP) and oversee trials that determine product safety, efficacy, medical usefulness, and value.
• Interpret and communicate results of Phase I–IV studies in preparation for new drug applications.
• Act as signatory on NDA submissions and clinical study and safety documents.
• Participate in product life‑cycle management from early development, seeking strategic innovations.
• Provide strategic oversight of vendor and CRO relationships and contribute to their governance committees.
• Lead and support regulatory filing activities, providing clear and compelling written and verbal communication.

• Clinician (M.D. or D.O.) with a specialty in psychiatry or neurology; prior management experience preferred.
• Supplementary degrees (Ph.D., M.P.H., M.B.A., etc.) are a plus; other clinical/scientific doctorates considered if supported by a clinician partner.
• 1–3 years of pharmaceutical or academic translational research experience for Associate Director; 3–6 for Director; 6–9 for Senior Director.
• Comprehensive knowledge of clinical medicine and science management, including defining objectives and achieving business outcomes on time and on budget.
• Strong written and verbal communication skills; proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Experience leading, managing, and motivating teams (internal staff, investigators, consultants).
• Advanced understanding of drug development principles, trial implementation, management, and reporting.
• 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 successful regulatory filings is advantageous.
• Knowledge of health‑value creation, financial assessment (e.g., NPV), project planning, budgeting, market research, and commercialization strategies.
• Willingness to travel 30% of the time, including weekends and internationally.

• Accountability for results and strategic execution.
• Strategic thinking and problem solving with a customer‑centric focus.
• Effective communication, influence, and respectful collaboration.
• Professional development and empowerment.

Minimum $ – Maximum $ plus incentive opportunity. The stated range reflects typical starting pay for individuals hired in the United States.

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

Otsuka is an equal‑opportunity employer. All qualified applicants are encouraged to apply. Consideration for employment is made 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 to receive assistance.