Preclinical Research & Pk Pd Mgr

Detalles de la oferta

.**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


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

Laboratorista-Toma De Muestras Sanguíneas

**Vacante para la empresa Grupo Castillo en Cuauhtémoc, Ciudad de México**: IMPORTANTE LABORATORIO DE ANALISIS CLINICOS, SOLICITA: LABORATORISTA-TOMA DE MUES...


Grupo Castillo - Veracruz

Publicado 8 days ago

Desarrollador De Negocios

Eaton's EPG CHD EP LATAM division is currently seeking a Desarrollador de Negocios. **What you'll do**: **FUNCION PRINCIPAL** Identificar, desarrollar y cer...


Eaton - Veracruz

Publicado 8 days ago

Encuestadores Tercera Edad

**Vacante para la empresa LA CASA DE TOÑO en Benito Juarez, Tacubaya, San Pedro De Los Pinos -Benito Juárez, Ciudad de México**: Encuestadores LA CASA DE TO...


La Casa De Toño - Veracruz

Publicado 8 days ago

Encuestador De Campo

Únete a nuestro gran equipo de abajo en Inmega. _*Encuestador de campo* *¿Qué t - frecemos?* Ingr so libre sema - de $2100 Apoyo de Pasajes me - al: $1,08...


Inmega Investigación De Mercados S.C - Veracruz

Publicado 8 days ago

Built at: 2024-11-22T04:35:58.450Z