Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Senior Clinical Pharmacology Medical Lead(MD)
YOUR TASKS AND RESPONSIBILITIES:
The primary responsibilities of this role, Senior Clinical Pharmacology Medical Lead, are to:
- The Senior Clinical Pharmacology Medical Lead is fully responsible as a physician for all Oncology and medical related Clinical Pharmacology aspects for drug candidates in Oncology on the project level.
- He/she works independently, is medically responsible for all core CP studies and provides medical expertise to key components of CP in Oncology drug development (early and late clinical phases) such as dose/schedule, Pharmacokinetic/Pharmacodynamic (PK/PD), QT/QTc and Drug-Drug-Interaction.
- He/she drives the medical component of CP strategies in Oncology ensuring progression through key development milestones beyond market authorization and in Life-Cycle-Management (LCM).
- He/she is responsible for the ongoing benefit/risk assessment of assigned drug candidates and that relevant actions and decisions are taken as appropriate.
- The CP Medical Lead works in close alignment with the respective Clinical Pharmacology Lead on the Clinical Pharmacology strategy for the assigned drug candidate.
- He/she is responsible for the development of a competitive state-of-the–art Clinical Pharmacology medical part of the label which allows an optimal positioning of the drug in the market.
- He/she works closely with the Head of CP Medical Leads and interacts with other Clinical and Operational functions within the SBU Oncology as well as with Regulatory Affairs, Pharmacovigilance and relevant Clinical and Operational functions within R&D to ensure an efficient communication and development according to state-of the art processes.
- He/she may also act as a Clinical Pharmacology Lead (CPL)
- The CP Medical Lead contributes to preparation of submission documents, health authority and ethics committee meetings and is counterpart for external key opinion leaders.
WHO YOU ARE:
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- The successful candidate will be an MD or MD/PhD trained in Oncology, ideally with experience in Clinical Pharmacology and Drug Development
- Full qualification as physician with a minimum of 4 years of clinical experience
- Ability to act as medical officer in the area of Oncology
- Proven understanding of the complexities of clinical development, ideally with experience in all phases of clinical development
- Strong ability to interpret clinical data and their relation to the clinical setting
- Industry experience in applications of Basic Research and/or Translational Medicine with the ability to cross between them
- Capable of working self-dependently and on own initiative
- Team player with ability to lead teams within the Matrix organization
- Excellent communication and organizational skills
- Fluency in English is mandatory. Command of a second major European language is an asset.
State: New Jersey
Reference Code: 50240
Functional Area: Biological R&D
Entry Level : Professional