Description
Otsuka is seeking a Director, Global Clinical Development (GCD) based Remotely or in our Princeton, NJ or Rockville, MD 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 Rheumatology, Immunology and Specialty Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Associate Director/Director/Senior Director, Global Clinical Development include the following:
- 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 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) 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.
Requirements
Detailed Description of Required Qualifications:
- A clinician (M.D., or D.O.) preferably a rheumatology, nephrology or immunology background, 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.
- 3-6 years of experience in the pharmaceutical industry or in academic translational clinical research.
- 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.
- 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). While not essential, prior personnel management experience, will support position at entry (Associate Director/Director/Senior Director).
- 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.
- 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. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.
- Willingness to travel 30% of time, over weekends and ability to travel internationally.
