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Clinical Pharmacology Lead (m/f/d)

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Bayer

20d ago

  • Job
    Full-time
    Senior & Expert Level
  • Research & Development
    Healthcare
  • Berlin

AI generated summary

  • You need a PhD, MD, or PharmD with extensive Clinical Pharmacology and Oncology experience, strong PK/PD knowledge, leadership skills, and fluency in English; a second language is a plus.
  • You will execute clinical pharmacology strategies, manage studies, collaborate with teams, and support regulatory submissions in Oncology drug development and Life Cycle Management.

Requirements

  • PhD, MD or PharmD with at long-term extensive expertise in the area of Clinical Pharmacology and Oncology Drug Development; of this, at least several years of experience must be in pharmaceutical industry or equivalent (e.g., FDA)
  • Strong background and demonstrated expertise in Clinical Pharmacology, PK and PK/PD including model-based drug development as evidenced by major Regulatory submission experience (e.g. NDAs, CTDs, INDs), scientific publications and presentations at major meetings
  • Industry experience in applications of Basic Research and/or Clinical Research with the ability to translate preclinical projects to the clinic.
  • Proven ability to manage strategic, scientific and operational aspects of development projects from a Clinical Pharmacology perspective
  • Evidence of leadership skills to direct and steer a team of experts, awareness of responsibility, efficient analytical thinking and working methods
  • Capable of working independently, excellent communication and organizational skills
  • Ability to handle conflict, highly resilient
  • Very good knowledge of written and spoken English; command of a second major language is an asset

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

FAQs

What is the main role of the Clinical Pharmacology Lead (CPL) Oncology at Bayer?

The main role of the CPL Oncology is to bring extensive experience in Clinical Pharmacology for all phases of Oncology drug development projects and to optimize decisions on drug development, particularly the dosing strategy, while managing interactions with key opinion leaders (KOLs) and regulatory authorities.

What qualifications are required for this position?

Candidates must have a PhD, MD, or PharmD with extensive expertise in Clinical Pharmacology and Oncology Drug Development, along with experience in the pharmaceutical industry or equivalent, such as the FDA.

What kind of experience is preferred for this role?

At least several years of experience in Clinical Pharmacology, PK and PK/PD, including model-based drug development, as evidenced by major regulatory submissions, scientific publications, and presentations at significant meetings.

What are some key responsibilities of the Clinical Pharmacology Lead?

Key responsibilities include building end-to-end CP strategies, driving technical excellence, implementing CP and PK/PD aspects, designing and evaluating core CP studies, managing CP sections for regulatory documents, and fostering collaborations with partners.

Is proficiency in multiple languages required for this position?

Very good knowledge of written and spoken English is required, and command of a second major language is considered an asset.

What personal qualities are important for this role?

Important qualities include leadership skills, the ability to manage strategic, scientific, and operational aspects of projects, strong communication and organizational skills, conflict management abilities, and resilience.

What is the work environment like at Bayer?

Bayer promotes a community of brilliant and diverse minds, encouraging collaboration, creativity, and innovation to tackle major global challenges.

Where is this position located?

The position is located in Berlin, Germany.

Does Bayer support diversity and inclusion in their hiring process?

Yes, Bayer welcomes applications from all individuals and is committed to treating all applicants fairly, avoiding discrimination based on various characteristics.

How can I apply for the Clinical Pharmacology Lead position?

You can apply for the position by following the application instructions provided on the Bayer careers website or the specific job posting.

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Bayer

Science for a better life

Science & Healthcare
Industry
10,001+
Employees
1863
Founded Year

Mission & Purpose

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power. Our products help address some of today’s biggest challenges, including global population growth, an aging society and the need to make efficient – and, wherever possible, sustainable – use of natural resources. In line with our mission “Bayer: Science For A Better Life,” we aim to improve people’s quality of life by preventing, alleviating or curing diseases. We also help provide an adequate supply of high-quality food, feed and renewable plant-based raw materials. For these endeavors, we focus on developing and successfully commercializing innovative products and solutions based on scientific knowledge.