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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.

Clinical Pharmacology Lead (m/f/d)

The Clinical Pharmacology Lead (CPL) Oncology will bring an 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 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

• 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

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.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location: Germany : Berlin : Berlin

Division: Pharmaceuticals

Reference Code: 829514