The Senior Scientist Clinical Pharmacology will help develop and implement clinical pharmacology programs that support product development, registration, differentiation and personalization. The Senior Scientist will interact with team members to identify and define mechanisms of action, biomarkers and new drug targets. The Senior Scientist is expected to help design clinical pharmacology trials and select pharmacokinetic (PK)/pharmacodynamic (PD) /biomarker assessments in all phases of development, work on development of physiologically-based pharmacokinetic (PB-PK) models extrapolating animal to human and within human for prediction of changes in PK with new formulations, disease state, pediatric, etc., conduct PK/PD analysis and reporting, contribute relevant sections to regulatory filings, work with pharmacometricians to develop PK/PD models and contribute to commercial strategies.
Help develop and execute Clinical Pharmacology strategy for given programs
Collaborate with clinical development to design and implement innovative early clinical development strategies from first-in-man through pharmacological/biomarker proof of concept (Phase Ib/Phase 2a)
Identify new drug targets and biomarkers through analysis of drug mechanism of action and patient characteristics (e.g., phenotype, genotype, etc.)
Provide input to project teams on biopharmaceutics, pharmacogenomics and biomarkers.
Work on development of physiologically-based pharmacokinetic models extrapolating animal to human and within human for prediction of changes in PK with new formulations, disease state, pediatric, etc.
Help design clinical pharmacology trials and is responsible for the generation of protocol outlines
Coordinates with bioanalytical scientists on types of analytes, limits of quantitation, and response range required of the bioanalytical methods used to support clinical trials.
Analyzes PK and PD data using non-compartmental and compartmental methods and prepares PK and PD sections of study reports and regulatory submissions documents.
Works with pharmacometricians to develop PK/PD/efficacy models.
Prepares and may present PK/PD information to internal clinical development and commercialization teams, regulatory agencies, and scientific boards and at investigator meetings.
Provides input to Department Head on departmental practices, templates and workflows.
Minimum of 5% travel based on business needs
REQUIRED Minimum of PhD or PharmD required Minimum of 2-5 years PK/PD experience required Able to work with minimal supervision and think independently Has demonstrated success in technical proficiency, scientific creativity and collaboration with others. Has worked on problems in which analysis of data requires evaluation of identifiable factors Solid understanding of clinical pharmacology with knowledge of PK/drug metabolism and human physiology Mathematical computing skills Ability to create written summaries and presentations using MS Office (Word, Excel, PowerPoint, Outlook) and Sigma Plot Experience with PK/PD software (e.g., WinNonlin) and plotting software (e.g., R, SigmaPlot, etc.)
PREFERRED Knowledge of pharmacology related to CNS and Cardio-renal Knowledge of Physiologically-based PK modeling with use of SimCYP or GastroPlus Post-doctoral clinical pharmacology experience or 1 to 2 years PK/PD experience in pharmaceutical industry Experience in the preparation of summaries and reports for regulatory submissions
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a big venture company at heart, applying creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion ( 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
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.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.