Director, Global Clinical Development
About The Position
Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department. OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. Our team is collaborative, innovative with a mantra of “acting as though the company was our own.” Our responsibilities range from due-diligence evaluations, where we stress-test others’ development plans, to development and implementation of our own global development & commercialization plans (GDCP). The GDCP translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials. Its goal is to efficiently evaluate the product’s potential and probability of success, support an effective commercial launch and plan for meaningful innovations to improve or expand the value of the initial product for our global customers (patients, prescribers and payors).
Requirements
- A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect).
- Experience in the pharmaceutical industry or in academic translational clinical research 6+ years 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.
- 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.
- Complete understanding of the global regulatory requirements.
- Dedication to assigned, developed projects and project goals.
- Appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.
Nice To Haves
- 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.
- Prior personnel management experience, will support position at entry (Associate Director/Director/Senior Director).
- 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.
- 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.
Responsibilities
- Design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
- 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 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
