Director Global Clinical Development (nephrology)
Company: Otsuka Pharmaceutical
Posted on: September 22, 2022
- Otsuka is seeking a Director, Global Clinical Development
(remote) 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 nephrology 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
- 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
- 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
- Involved in product life cycle management from the earliest
stages of development, constantly seeking innovations to add value
- 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
Detailed Description of Required Qualifications:
- A clinician (M.D., or D.O.) preferably nephrologist 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.
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
- 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
- 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
- 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
Come discover more about Otsuka and our benefit offerings;
This job description is intended to describe the general nature and
level of the work being performed by the people assigned to this
position. It is not intended to include every job duty and
responsibility specific to the position. Otsuka reserves the right
to amend and change responsibilities to meet business and
organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants
are encouraged to apply and will receive consideration for
employment without regard to their protected veteran or disabled
status, or any protected status.
Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and
employees. Uploading documentation with proof of full vaccination
record or an Otsuka approved accommodation will be required during
the pre-employment process as permitted by law. New hires must be
fully vaccinated unless there is an approved accommodation prior to
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Keywords: Otsuka Pharmaceutical, Trenton , Director Global Clinical Development (nephrology), Healthcare , Princeton, New Jersey
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