Director, Global Clinical Development
About The Position
Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), a U.S.A. subsidiary, which houses the Global Clinical Development (GCD) department. OPDC-GCD is a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. The team is collaborative and innovative, operating with a mantra of “acting as though the company was our own.” Their responsibilities range from due-diligence evaluations, where they stress-test others’ development plans, to the development and implementation of their 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. The 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 global customers (patients, prescribers, and payors).
Requirements
- A clinician (M.D., or D.O.) preferably a nephrologist or immunologist including prior management experience (direct or indirect).
- Experience in the pharmaceutical industry or in academic translational clinical research (typically 3-6 years for Director level).
- A thorough knowledge of clinical medicine and science management, including 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.
- 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.
- 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 (e.g., net present value), project planning and budgeting, market research, and commercialization strategies.
- Dedication to assigned, developed projects and project goals.
- Willingness to travel 30% of time, over weekends and ability to travel internationally.
Nice To Haves
- Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.).
- 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.
- Demonstrated experience in successful regulatory filings.
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.
- Consult with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully apply their recommendations toward optimizing trial objectives, designs, and protocols.
- Develop 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.
- Author program strategies (i.e., GDCP) and oversee trials essential for determining the clinical safety, efficacy, medical usefulness, and value of drug or medical device product candidates.
- Interpret and communicate results of Phase I-IV investigations in preparation for a new drug.
- Act 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.
- Provide strategic oversight in vendor and CRO relationships, and provide clinical input into their governance committees.
- 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
- Other company provided benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
