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Senior Clinical Pharmacology Lead
vor 4 Monaten
**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re 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 you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**
**Senior Clinical Pharmacology Lead M/F/d**
**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.**
**YOUR TASKS AND RESPONSIBILITIES**
- Closely work with a Senior Director Clinical Pharmacology Lead (CPL) and represent Clinical and Quantitative Pharmacology (CQP) Oncology in project teams and related translational and clinical teams
- Ensure adequate consideration and implementation of all aspects of Clinical Pharmacology (CP), Quantitative Clinical Pharmacology (QCP), Pharmacokinetics (PK) and Pharmacokinetics / Pharmacodynamics (PK/PD) including model-informed drug development (MIDD) approaches from early research to Life Cycle Management (LCM)
- Contribute to the development and execution of the CP, QCP and MIDD strategy in line with the overall development and submission strategy for assigned projects
- Provide input to dose / schedule finding, selection and justification in line with Project Optimus in collaboration with other functions within Translational Sciences (TSO), Research and Early Development Oncology RED ONC), Oncology Development as well as Toxicology, DMPK and Pharmacometrics
- Provide CP, QCP, PK and PK/PD advise and expertise to all kind of Early Clinical Development studies and contribute to design, plan, execute and evaluate core CP Studies required for a competitive label
- Support relevant Late Clinical Development and Global Medical Affairs (GMA) studies with CQP components such as dosing strategies, drug interaction potential and exposure response/safety analysis in close collaboration with the respective Oncology Development / GMA functions and study teams
- Closely interacts with other functions within TSO, RED Oncology as well as within Oncology Development to define the best use of biomarker concepts in conjunction with modelling and simulation approaches for development projects
- Contribute to the evaluation and reporting of QCP related results and its impact on decision making and risk assessment in the context of the drug development project plan
- Constantly seek for and bring innovative approaches to CQP
- Representing CQP externally, e.g. in meetings with authorities or key opinion leader meetings, as appropriate
- Be responsible for content and timely provision of CQP input to documents such as IB, IMPD, study protocols, PSUR reports, study reports, IND documents as well as publications
- Provide CQP, PK and PK/PD expertise in due diligences of potential in licensing projects
**WHO YOU ARE**
- PhD, MD or PharmD with several years of experience in Clinical and Quantitative Clinical Pharmacology
- Experience in drug development and oncology of advantage
- Experienced in working as part of a team and in directing teams.
- Capable of working independently and on own initiative
- Open mind-set and innovative way of thinking
- Advanced communication and organizational skills Interest in interdisciplinary work
- Efficient analytical thinking and working methods, awareness of responsibility
- Ability to handle conflict, highly resilient
- Very good knowledge of written and spoken English. Command of a second major language is an asset.
**YOUR APPLICATION**
This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.
**Location**: Germany : Berlin : Berlin
**Division**: Pharmaceuticals
**Reference Code**:788794
