Director, Global Clinical Development

About the role

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is a U.S. subsidiary of Otsuka Pharmaceutical Co. located in Rockville, MD or Princeton, NJ. OPDC-GCD is a group of physicians and scientists responsible for leading clinical development activities for Otsuka's global health-care products.

Responsibilities

• Consults with patients or their representatives, clinical, regulatory, and scientific leaders, and thoughtfully applies recommendations toward optimizing trial objectives, designs, and protocols.
• Develops focused expertise to serve as an internal medical/scientific consultant to health economics, 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.
• Provides strategic oversight in 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 arguments 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.
• In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g., D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D.) may be considered if complemented by a team or consulting clinician.
• Experience in the pharmaceutical industry or in academic translational clinical research (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 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.
• A 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).
• An advanced understanding of drug development principles and clinical trial implementation, management, and reporting is essential and will be further developed, including: 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.
• Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
• A working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research, and commercialization strategies.
• Dedication to assigned, developed projects and project goals.
• An appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.
• A willingness to travel 30% of time, over weekends, and ability to travel internationally.

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

Full-time.