Associate Director, Medicinal Safety in Basking Ridge, New Jersey at DSI

Date Posted: 11/14/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position for Medicinal Safety (Toxicology) will lead nonclinical safety discussions (such as strategy for general toxicology studies, de-risking strategy and risk communication), as the MSRL Toxicology Representative, in the assigned Global Project Teams (GPTs). When assigned as Study Director, incumbent will be responsible for preclinical toxicology studies conducted at CROs in the West. Position will also contribute to the quality of nonclinical safety sections of regulatory documents to assure the integrity of such documents. Incumbent will construct and review nonclinical toxicology sections of regulatory documents including but not limited to investigational and new drug applications. Position will contribute to nonclinical safety studies’ protocol design, execution of toxicity studies’ conduct, safety data collection and interpretation, risk communication, and interact with regulatory authorities after consultation with supervisor. Additionally, incumbent will work effectively with global multi-disciplinary project teams while operating in collaboration with Global Medicinal Safety colleagues on emerging nonclinical safety issues and due diligence assignments as needed. Incumbent will also represent MSRL in interactions with Senior Management.

Responsibilities:
  • Serves as MSRL Toxicology Representative in Global Project Teams (GPTs), oversees nonclinical Study Director at CROs in the West, contributes to execution of toxicology studies’ protocol design in accordance to the ICH directives, and interpretation of such nonclinical safety data for use in global Regulatory Agencies’ applications. Proactive in nonclinical safety problem identification, risk communication, and contributes to resolutions.
  • Contributes to preparations and reviews of regulatory nonclinical safety data draft documents; engages in supervised interactions with regulatory authorities as needed especially in assigned drug development projects. Supports and contributes to selection of toxicology consultants/experts for newly emerging safety issues for on- and real-time resolution.
  • Day-to-day adherence to good working knowledge of non-clinical safety-related guidance, guidelines and regulations as required by regional Regulatory Agencies in ICH member regions and familiarity with the ICH processes for drug development. Supports and contributes to internal/external collaborations on drug development and safety biomarker development.
  • Supports effective collaboration with global multi-disciplinary team as nonclinical toxicology representative and DSI in-licensing effort and due diligence.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • PhD or DVM (Vet.)
  • Board Certified Toxicologist preferred, but not required
  • Minimum of 5+ years of drug development experience in the pharmaceutical industry as a practicing toxicologist. Wet lab or bench work capabilities will be considered as an asset. FDA regulatory experience is not required, but highly desired.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.