At Bayer were visionaries, driven to solve the worlds toughest challenges and striving for a world where ''Health for all, Hunger for none is no longer a dream, but a real possibility. Were doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining impossible. There are so many reasons to join us. If youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, theres only one choice.
Clinical Pharmacology Lead (all genders)
The incumbent for this position may be based in the United States (US) or several European countries. Bayer Talent Acquisition is accepting applications for these locations under one global job posting which follows each country''s individual employment laws. As such, applicants should expect to experience differences in the application process which are unique from a single country posting.
The Clinical Pharmacology Lead (CPL) Oncology will bring extensive experience and knowledge of the Clinical Pharmacology (CP) field for all phases of Oncology drug development projects. This position will play a key role in management of interactions with KOLs as well as with regulatory authorities and will work closely with PK specialists, Translational Sciences, Pharmacometrics, Research, Clinical Development, Regulatory, Medical Affairs and Commercial/Marketing functions. Ultimately, the position aims to optimize decisions on drug development projects (particularly the dosing strategy) and advance products to regulatory approval with a competitive and state of the art product label.
YOUR TASKS AND RESPONSIBILITIES
* Build and execute an end to end clinical pharmacology (CP) strategy for all development programs.
* Complete globally relevant CP activities from early research to Life Cycle Management (LCM) with cross functional teams.
* Drive technical excellence and innovation within RED ONC through core projects and collaborations.
* Represent Clinical Pharmacology (CP) Oncology in Product Teams (PTs) and related clinical teams.
* Implement CP and PK/PD aspects, including model based development approaches for Oncology drug development.
* Design, plan, execute, and evaluate core CP studies, supporting Oncology Development and Global Medical Affairs (GMA) studies.
* Lead and manage the preparation of CP sections for major clinical and regulatory documents and provide global CP submission support.
* Identify new collaboration opportunities and manage relationships with partners to drive clinical pharmacology excellence.
WHO YOU ARE
1. PhD, MD or PharmD with long term extensive expertise in the area of Clinical Pharmacology and Oncology Drug Development; of this, at least several years of experienc