Sr. Scientist – Preclinical Development & Safety Group

Job Locations US-NJ-Princeton
Requisition ID


Provides support to ongoing and planned non-clinical programs. Reviews, evaluates, and analyzes and reports data for in vivo and in vitro pharmacology, DMPK and toxicity studies. Understand and identify mechanism of toxicity and pharmacological effects that might produce adverse effects in clinical trials or upon marketing. Work closely with the non-clinical as well as the clinical pharmacology and bio-analytical team members in order to support the activities related to INDs, NDAs as well as early stage compounds. Support regulatory activities related to drafting, review and filing of non-clinical sections of INDs, IBs, annual reports and NDAs. 


Job Responsibilities

  • Review, evaluate, interpret, report, and compile non-clinical toxicology, pharmacology, ADME, drug safety and bioanalytical data.
  • Draft, review and finalize non-clinical regulatory documents, including IBs, INDs and NDAs.
  • Support the development of non-clinical and clinical protocols.
  • Manage contract laboratories and provide review and quality control of non-clinical reports when appropriate.
  • Attend scientific meetings and regulatory agencies. Present research findings at scientific meetings and conferences and submit scientific manuscripts for publication in peer-reviewed journals.
  • Ensures compliance with regulations relevant to the conduct and reporting of non-clinical studies. 



  • Extensive knowledge of pharmacology, toxicology, pathology, DMPK, drug development, and global regulatory requirements.
  • Complete understanding of the current scientific advancements in the field. 
  • Experience in the early drug development of CNS, oncology, cardiorenal, and/or immuno-inflammatory diseases. 
  • Good knowledge of toxicology related to small molecules and biologics. 
  • Good knowledge and understanding of the drug discovery and development processes.
  • Experience in interacting with and managing studies at external vendors. 


  • Excellent communication and presentation skills.
  • Experience in PK/PD, allomeric scaling, analysis and modeling of non-clinical data.
  • Strong computer skills with demonstrated experience in working with the Microsoft Office suite. 
  • Experience with electronic document management systems, data analysis software such as (Phoenix NLME, NONMEM, R) and electronic submission platforms is a plus. 

Travel 20%


Education and Related Experience

  • MS or PhD in Pharmacology, veterinary Science, toxicology or pathology (or both). Minimum of 4-6 years (MS) 3 years (PhD) of relevant experience.


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 a youthful spirit of 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 45,000 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 Learn more about Otsuka in the U.S. at

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