Pre Clinical Research and PK PD

1. Responsible and accountable to take the lead defining the pre- clinical and pharmacology (PK/PD) strategy across all categories, brands, and products in global, regional, and local project teams. 2. Responsible and accountable for developing pre-clinical and clinical pharmacology evidence generation plans, designing and execution of studies, approval of data sets, data analysis, and study reports. 3. Responsible for the identification, qualification, selection, contracting and oversight of pre-clinical and PK/PD vendors. 4. Budgeting, and budget oversight for pre-clinical and PK/PD initiatives. 5. Understanding current and emerging development in the pre-clinical and clinical pharmacology arena in support project and category teams to optimize strategic plans and development for new and existing products. 6. Is close to the customer and co-creates solutions for their needs by driving pre-clinical and clinical pharmacology excellence through all of BCH's categories. 7. Ensuring a robust and clear messaging to R&D and RMSQC functions which allows them to properly assess the performance of new products from a pre-clinical and pharmacological point of view. 8. Plans, executes, and oversees PK/PD modeling and simulation to inform and support new product development and bridging across existing clinical data. 9. Responsible for authoring relevant pre-clinical and clinical pharmacology briefing materials to justify BCH's development strategy and defending BCH's position with Health Authorities (HA) and regulators. 10. Contributes to pre-clinical and clinical pharmacology responses to HA inquiries (incl., but not limited to notices of non-compliance or deficiency, clinical study design questions) to support marketing applications. 11. Contributing author of critical regulatory dossier components.

• Education: A degree in and/or postgraduate qualification e.g., PhD in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Natural Sciences or other related disciplines.
• Experience: Substantial experience (at least 3-5 years) in Pharmacokinetics and Pharmacodynamics and conduct of pre-clinical studies (either in pharmaceutical industry or CRO) ideally in a global setting and in diverse therapeutic areas.
• Proficiency in and hands-on experience in PK/PD computational tools (e.g., Phoenix WinNonlin) combined with strong analytical skills and the ability to handle large amounts of data and information.
• Knowledge of applicable regulations and requirements e.g. GMP, GCP, FDA and EMA Guidance.
• Demonstrated ability to work in a highly collaborative, multidisciplinary team setting.
• Excellent verbal and written communication skills.
• Self-directed and highly motivated researcher, with willingness to learn new tools and approaches.
• Deep and unique understanding of BCHs critical APIs
• Competencies: Team player which cocreates for customers, proactively asks for and gives feedback, and has ability to handle pre-clinical and clinical pharmacology strategies and initiatives on a global, regional, and local level.
• Demonstrates strategic thinking as well as good business- and external trends insights. Focuses on outcomes defines and delivers highest pipeline-, team-, and organizational-impact-outcomes.
  
  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.
  
  Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee. What we offer
• Competitive compensation package consisting of an attractive base salary and annual bonus.
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Wellness programs and support
• Employee discount scheme
• State of the art offices
• International career possibilities
• Flexible and and Hybrid working
• Help with home office equipment
• Volunteering days
• Support for professional growth in a wide range of learning and development opportunities
• We welcome and embrace diversity providing an inclusive working environment
The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.