Associate Director, Clinical Pharmacology in Basking Ridge, New Jersey at DSI

Date Posted: 11/22/2019

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:

The Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration.
Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/ Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and development teams.

Responsibilities:
  • Responsible for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with high-level supervision; participates in due diligence activities and represents global function on study and project teams
  • Produces independent writing for publications & regulatory documents
  • Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and can conduct/develop PK-PD and Pop PK-PD analyses,
  • Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management, and outside vendors; works independently for all phases of studies
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Bachelor’s degree and Master’s degree, MD or Ph.D. in pharmacology or pharmaceutical sciences, or a PharmD with a clinical pharmacology research fellowship.
  • 5+ years industry experience
  • Hands on modeling and simulation experience using NonMem and other statistical/data programing software such as R or SAS.
  • Experience in designing and executing clinical pharmacology studies and plans.
  • Excellent communication skills
  • Experience working in a matrix team environment
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.