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Associate Director, Clinical Pharmacology (all genders) - full-time/part-time possible

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Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role:
Associate Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from the early to late-stage clinical development. This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.
You provide strong leadership for integrating individual functional contributions, developing clinical pharmacology strategy in alignment with the overall clinical development plan, and executing the program strategy/plan. The scope includes programs from exploratory development (ED) through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas. You ensure that clinical pharmacology strategy is developed, aligned (with cross-functional development plans), endorsed and executed to support the indication, patient population, and phase of development while taking into account the competitive landscape. You represent and promote clinical pharmacology & MIDD strategy with internal and external stakeholders, provide in-depth CP, PK/PD and MIDD advice and expertise and lead clinical pharmacology expert team and deliver on dose and posology decisions, from FIH starting dose through submission and beyond.
Location: Hybrid preferred, Remote possible (if remote working policy allows) with travel as required
Who you are:

  • 3
  • years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experience
  • Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmacometrics, pharmaceutics, statistics, engineering or mathematics
  • Fluency in English
  • Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas. Experience supporting large molecules, including anti-body drug conjugates and bsAB is preferred
  • Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc
  • Excellent knowledge of regulatory requirements and submission across the main regions
  • Good understanding about translational sciences such as quantitative pharmacology, safety and biomarkers
  • General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus
  • Hands on modeling expertise is a plus

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!

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Associate Director, Clinical Pharmacology (all genders) - full-time/part-time possible

Merck KGaA
Darmstadt
Vollzeit, Unbefristet

Veröffentlicht am 20.12.2024

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