Manager, Clinical Pharmacology QCP in Basking Ridge, New Jersey at DSI

Date Posted: 1/13/2020

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 will be part of the Quantitative Clinical Pharmacology (QCP) team and support drug development and commercialization activities. It is accountable for the Clinical Pharmacology and Model-Based Drug Development (MBDD) plans and deliverables. The primary responsibilities of Clinical Pharmacology are to establish PK/PD/efficacy/safety relationships in the clinical setting, to drive the development of potential products and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of study designs, protocols, reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager, Clinical Pharmacology is expected to identify, generate and execute study protocols with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations, Global Project Management, Bioanalysis, and Drug Metabolism to design, develop, implement and monitor execution of strategies as well as short- and long-term experiments to advance clinical development.

Responsibilities:

Serve as QCP representative on Clinical studies or take a lead on Clinical pharmacology studies
Applies guidelines for assay validation and QC; monitors compliance

Serve as QCP sub-team leader and represent the QCP function at project teams

Perform modeling and simulation in support of clinical development of drug candidates

Maintain exploratory modeling and simulation workflows. Perform quality checks on modeling conducted by other scientists.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor’s degree (BS in Life Sciences, Pharmacy or Nursing is preferred); Advanced degree in a related field (MS, MPH, PhD or Pharm. D higher) strongly preferred.

5+ years with a BS degree, 3+ years with a MS degree and 1+ years with a doctoral degree. Experience should be in clinical development and performing modeling and simulation is required.

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.