**Bayer es una compañía global con competencias centradas en los campos de las ciencias de la vida de la salud y la agricultura. Sus productos y servicios están diseñados para beneficiar a las personas y mejorar su calidad de vida. En Bayer tienes la oportunidad de ser parte de una cultura en la que valoramos la pasión de nuestros colaboradores por innovar y darles el poder de cambiar.**
**PreClinical Research & PK PD Mgr**
**Your Tasks & Responsibilities**
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.
11. Contributing author of critical regulatory dossier components.
**Who You Are**:
- 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.
**Período de aplicación**:
- Del 27 de Agosto al 10 de Septiembre 2024**Código de referencia**:
- 826664**División**:
- Consumer Health**Ubicación**:
- Mexico : Ciudad de México : Ciudad de México**Área funcional**:
- Registro Farmacéutico**Grado de posición**:
- VS 1.2**Tipo de empleo**:
- Permanente**Tiempo de trabajo**:
- Indeterminado