Clinical Pharmacology Lead (m/f/d)

Bayer; Deutschland; Vor Ort; EUR 80.000 - 150.000; Vollzeit

Zusammenfassung

Join a forward-thinking company as a Clinical Pharmacology Lead in Oncology, where you'll leverage your extensive expertise to drive innovative drug development strategies. In this pivotal role, you will collaborate with cross-functional teams to optimize drug development decisions and advance products to regulatory approval. Your leadership will guide critical projects, ensuring technical excellence while fostering partnerships that enhance clinical pharmacology capabilities. This is a unique opportunity to make a significant impact on global health challenges and contribute to groundbreaking advancements in oncology. Be part of a dynamic team that values your insights and passion for innovation.

Qualifikationen

• Extensive expertise in Clinical Pharmacology and Oncology Drug Development.
• Experience in pharmaceutical industry or equivalent with regulatory submissions.

Aufgaben

• Build and execute clinical pharmacology strategy for development programs.
• Lead CP studies and manage relationships with partners for excellence.

Kenntnisse

Clinical Pharmacology

Oncology Drug Development

PK/PD Modeling

Leadership Skills

Analytical Thinking

Communication Skills

Conflict Management

Bilingual (English + 1)

Ausbildung

PhD

MD

PharmD

Jobbeschreibung

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 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, working 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

1. Build and execute an end-to-end clinical pharmacology (CP) strategy for all development programs.
2. Complete globally relevant CP activities from early research to Life Cycle Management (LCM) with cross-functional teams.
3. Drive technical excellence and innovation within RED ONC through core projects and collaborations.
4. Represent Clinical Pharmacology (CP) Oncology in Product Teams (PTs) and related clinical teams.
5. Implement CP and PK/PD aspects, including model-based development approaches for Oncology drug development.
6. Design, plan, execute, and evaluate core CP studies, supporting Oncology Development and Global Medical Affairs (GMA) studies.
7. Lead and manage the preparation of CP sections for major clinical and regulatory documents and provide global CP submission support.
8. Identify new collaboration opportunities and manage relationships with partners to drive clinical pharmacology excellence.

WHO YOU ARE

1. PhD, MD or PharmD with 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).
2. 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.
3. Industry experience in applications of Basic Research and/or Clinical Research with the ability to translate preclinical projects to the clinic.
4. Proven ability to manage strategic, scientific and operational aspects of development projects from a Clinical Pharmacology perspective.
5. Evidence of leadership skills to direct and steer a team of experts, awareness of responsibility, efficient analytical thinking, and working methods.
6. Capable of working independently, excellent communication and organizational skills.
7. Ability to handle conflict, highly resilient.
8. 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