PRECLINICAL RESEARCH & PK PD MGR

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.
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.
Who You Are.
Education.
A degree in and/or postgraduate qualification e.
., 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.
., 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.
.
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.
Bayer offers a wide variety of competitive compensation and benefits programs.
If you meet the requirements of this unique opportunity and you have the “Passion to Innovate” and the "Power to Change", we encourage you to apply now.
Job Postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.
To all recruitment agencies Bayer does not accept unsolicited third-party resumes.
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.
Bayer Is committed to providing access and reasonable accommodations in its applications process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodations when the recruiter contacts them for the process.
Período de aplicación.
Del 27 de Agosto al 10 de Septiembre Código de referencia.
División.
Consumer Health     Ubicación.
Mexico.
Ciudad de México.
Ciudad de México       Área funcional.
Registro Farmacéutico     Grado de posición.
VS 1.
      Tipo de empleo.
Permanente  Tiempo de trabajo.
Indeterminado