Senior Director, Clinical Pharmacology

Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: January 17, 2022

Job Description:

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThe primary responsibilities of this position are to lead studies and projects independently, contribute to due diligence/licensing and strategic decisions, and represent QCP in KOL and regulatory interactions. This position requires advanced understanding of PK-PD and Pop PK-PD, ER/CUI analyses, Phase 1-4 studies, physiological/ pharmacological aspects of the drug, biomarkers, pharmacogenomics, companion diagnostics, and novel approaches to drug development. The person in this position works independently for global projects while establishing KOL and regulatory interactions and interacting with outside vendors as well as regional and global study team members and senior management. -Responsibilities

• Independently leads clinical pharmacology studies and contributes the clinical pharmacology and pharmacometrics strategy to global projects; participates in business development and contributes to cross-functional, regional, and global strategic decisions
• Consistently and effectively writes regulatory documents (IBs, background documents, CTDs etc.)
• Serves as an expert in and can conduct as necessary PK-PD and Pop PK-PD, ER/CUI analyses, in support of all types of Phase 1-4 studies
• Establishes and participates in KOL and regulatory interactions for programs; interacts with regional and global study and project team members and senior management, and outside vendors
• Mentor and leader for junior scientists in QCP -Qualifications:Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
  • PharmD with a clinical pharmacology research fellowship, Ph.D. in Pharmacology, Pharmaceutics, Pharmacometrics, or a related field -Experience Qualifications
    • 7 or More Years Industry Experience required and
    • 4 or More Years experience applying the principles of clinical pharmacology to advance clinical drug development and
    • 1 or More Years People management experience preferred - Travel - Ability to travel up to 20% Travel to Japan to build working relationships, coordinate work assignments, and provide lectures and training on advanced model-informed drug discovery and development approach 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.

Keywords: Daiichi Sankyo, Inc., Newark , Senior Director, Clinical Pharmacology, Executive , Basking Ridge, New Jersey