The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
The purpose of this position is to conduct population PK/PD analysis for pooled Phase 1 studies, perform trial simulation for Phase 2/3 studies, and write M&S reports. This position demonstrates significant knowledge of pooled Phase 1 studies, PK/PD and biomarker data, PK/PD analysis-ready data file derivation, complex disease modalities, regulatory guidelines pertaining to M&S, and programming and analytical software. This position works independently on complex studies/models and interacts effectively with project team members, CRO, and regulatory agencies.
Analyzes and presents pooled Phase 1 studies while delivering best practice elements and driving global standards
Conducts trial simulations for Phase 2/3 studies; characterizes the time course of disease progression for complex disease modalities
Writes M & S documents (e.g. M&S report, analysis plan, dataset specification)
Works independently on complex studies/models while interacting effectively with internal colleagues, external CROs, as well as regulatory agencies
PhD with a minimum of 6 years of industry experience, or MS with 8 years of industry experience or equivalent
Proficiency in quantitative analyses (including population PK, PK/PD, exposure-response, and drug-disease modeling) and clinical trial simulations
Prior experience in applying modeling and simulation to clinical development of oncology products, particularly ADCs
Familiarity with following systems: NONMEM, R, PsN, Xpose, WinNONLIN (Phoenix)
Solid proficiencies in written and verbal communication, interpersonal skills, problem scoping and planning, and the ability to participate in interdisciplinary teams.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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. Job Title Director Modeling and Simulation QCP
City Basking Ridge
Functional Area QCP
State New Jersey Associated topics: ad, alumni, demand, endowment, lead generation, mba, medical center, product market, public, relationship
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.