[Hiring] Senior Director, Global Clinical Development Psychiatry and Neurology @Otsuka Pharmaceutical Co., Ltd.

Role Description

Otsuka is seeking a Senior Director, Global Clinical Development remote based or in our Rockville, MD or Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of CNS and Digital Medicine products at different stages of development for a global health-care market.

• Consults with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs, clinical development plans and protocols.
• Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and other research project team members, and to external regulatory agencies.
• Authors program strategies (i.e., GDCP), protocols, study reports, and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.
• Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.
• Acts as the signatory on NDA submissions and clinical study and safety documents.
• Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.
• Provides strategic oversight in our vendor and CRO relationships and provides clinical input into their governance committees.
• Will help lead and support regulatory filing activities and documents, providing strategic direction and editing to provide concise, clear, and convincing argumentation in all such written and verbal communications.

Qualifications

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus.
• Experience in the pharmaceutical industry or in academic translational clinical research, 6-9 years for Senior Director levels is typically required depending on type of experience at application.
• A thorough knowledge of clinical medicine and science management.
• An ability to communicate effectively in meetings and via written and oral presentations is essential.
• Demonstrated experience leading, managing, and motivating team members.
• An advanced understanding of drug development principles and clinical trial implementation, management and reporting is essential.
• Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
• Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
• Complete understanding of the global regulatory requirements.
• Working knowledge of the principles of health value creation, including financial assessment, project planning and budgeting, market research and commercialization strategies.
• Dedication to assigned, developed projects and project goals.
• Willingness to travel 30% of the time, over weekends and ability to travel internationally.

Requirements

• Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity.
• Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role.
• This information is provided to applicants in accordance with states and local laws.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement, student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.