You play a key role in oncology drug development by coordinating pharmacology strategies, driving study design, and ensuring effective communication of results and plans across teams.
Anforderungen
- •PhD, MD, or PharmD required
- •Strong background in CP, PK, and PK/PD
- •Industry experience in Basic and Clinical Research
- •Evidence of leadership skills
- •Excellent communication and organizational skills
- •Fluent in English
- •Command of a second major language is an asset
Deine Aufgaben
- •Represent Clinical Pharmacology Oncology in teams.
- •Implement CP and PK/PD aspects in drug development.
- •Coordinate CP strategy and core studies.
- •Drive PK/PD activities for study design.
- •Provide expertise for core CP study execution.
- •Collaborate on pharmacology concepts for projects.
- •Evaluate CP results and adapt project plans.
- •Lead preparation of CP sections in documents.
Original Beschreibung
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| **Clinical Pharmacology Lead (m/f/d)** | | | | |
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As a Clinical Pharmacology Lead in Oncology, you play a pivotal role in optimizing drug development projects across all phases, particularly focusing on dosing strategies to advance products to regulatory approval with competitive labels. You collaborate closely with various teams, including PK specialists, Translational Sciences, and Regulatory Affairs, driving strategic decisions and incorporating novel technologies into the pipeline. Your leadership significantly shapes technical and scientific excellence within Bayer, pushing boundaries in clinical pharmacology.
**YOUR TASKS AND RESPONSIBILITIES**
* Independently represent Clinical Pharmacology Oncology in Product Teams and clinical teams
* Ensure consideration and implementation of CP and PK/PD aspects for all phases of Oncology drug development
* Set up, execute, and coordinate CP strategy including core studies aligned with development and submission strategy
* Drive PK/PD activities to support study design and dose/schedule selection for clinical studies
* Provide subject matter expertise to design, plan, execute, and evaluate core CP studies
* Collaborate with Research and Early Development Oncology to define pharmacology concepts for development projects
* Evaluate and report CP results, adapt project plans to avert risks, and communicate measures clearly
* Lead preparation of CP sections in major clinical and regulatory documents and provide global submission support
**WHO YOU ARE**
**Required Qualifications:**
* PhD, MD, or PharmD with extensive expertise in Clinical Pharmacology and Oncology Drug Development
* Strong background in CP, PK, and PK/PD including model-based drug development
* Industry experience in Basic Research and/or Clinical Research with ability to translate preclinical projects to clinic
* Evidence of leadership skills to direct and steer a team of experts
* Capable of working independently with excellent communication and organizational skills
* Fluent in English;
**Preferred Qualifications:**
* Command of a second major language is an asset
**Location:** Germany : Berlin : Berlin || Switzerland : Basel-City : Basel || United States : Massachusetts : Boston
**Division:** Pharmaceuticals
**Reference Code:**849998
**Job Segment:**
Clinical Research, Medical Research, Compliance, Regulatory Affairs, Pharmaceutical, Healthcare, Legal, Science