Director, Global Clinical Development

About the role

Otsuka is seeking a Director, Global Clinical Development (GCD) based remotely or in our Princeton, NJ or Rockville, MD offices. The role involves the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).

Responsibilities

• Consults with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.
• Develops focused expertise to serve as a clinical/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) 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.
• Helps lead and support regulatory filing activities and documents.
• Provides strategic direction and edits to provide concise, clear, and convincing argumentation in all such written and verbal communications.

Qualifications

• A clinician (M.D., or D.O.) preferably a geneticist, metabolic physician or rare disease expert, or immunology background
• Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus
• Experience in the pharmaceutical industry, clinical practice experience and/or academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director is typically required depending on type of experience at application)
• A thorough knowledge of clinical medicine and science management
• This entails defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality
• ≥ 5 years of involvement in clinical research or drug development in an academic or industry environment across clinical activities in Phases I through IV
• An ability to communicate effectively in meetings and via written and oral presentations is essential
• This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Demonstrated experience leading, managing, and motivating team members (e.g., internal staff and external investigators or consultants)

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
• Paid leave programs

Pay

$209,599.00 - $313,375.00, plus incentive opportunity

Schedule

Remote or in our Princeton, NJ or Rockville, MD offices