at Grifols Shared Services North America, Inc in Peoria, Illinois, United States
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
This is a REMOTE position
Summary
The Manager/Sr. Manager, Pharmacology (Non-clinical, Clinical and Quantitative Pharmacology) will be responsible for managing and executing non-clinical and clinical pharmacology (including pharmacometrics) functional deliverables in collaboration with internal and external partners in an effective and scientifically rigorous manner.
Manager
Primary responsibilities for role
+ Contribute to the design, execution, PKPD analysis, interpretation and reporting of non-clinical and clinical pharmacology studies (including FIH). This will be accomplished in close partnership with senior colleagues.
+ Independently represent Pharmacology as a core member of non-clinical and clinical study teams. The differentiation between the manager and senior manager levels is based on the ability to work independently and by demonstration of managing the expectations effectively.
Additional Responsibilities
+ Contribute to non-clinical and clinical study designs, author functional sections of non-clinical and clinical study protocols, and finalizing non-clinical and clinical study reports
+ Support leading internal pharmacology sub-team for early stage development
+ Align development plans with sub-teams, study teams and manager
+ Manage CROs for non-clinical, TK/PK and clinical pharmacology related studies and activities by developing study timelines, objectives, and budgets, ensuring accuracy of project progress and completion and pro-actively identifying hurdles and providing solutions
+ Analyze and interpret PK/PD data generated during conduct of the non-clinical and clinical studies while communicating results and impact of results in a timely and effective manner to study teams and development sub-teams (under oversight of senior clinical pharmacology colleague)
+ Provide pharmacology input and collaborate with key cross functional team members such as clinical operations, clinical development, biostatistics, translational sciences, data management, medical writing, regulatory, and safety and therefore must possess good communication and interpersonal skills.
+ Complete all required organizational trainings and requirements according to corporate timelines and adhere to the appropriate SOP and GxP guidelines.
Knowledge Skills & Abilties
+ Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software (Phoenix [NCA]) etc.) and statistical analyses methods used in analyzing pre-clinical and early clinical phase data
+ Knowledge of general regulatory process
+ Excellent written and oral communication skills including good presentation skills
+ Collaborative and flexible in personal interactions, ability to work proactively and effectively, with exceptional problem-solving skills
+ Exposure to biologics drug development. Knowledge of basic and clinical immunology is a plus.
Education
Doctoral degree (PhD or Equivalent training by experience [PharmD]) in clinical pharmacology, pharmacokinetics, pharmacology, toxicology, pharmaceutics, or relevant discipline.
Experience
From 3+ years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics, and other pharmacology components of non-clinical and early clinical trials within the pharmaceutical or biotech industry or academia.
Equivalency
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Sr. Manager
Additional responsibilities
+ Contribute to non-clinical and clinical study designs, author functional sections of non-clinical and clinical study protocols, and finalizing non-clinical and clinical study reports.
+ Lead internal pharmacology sub-team for early stage development
+ Align development plans with sub-teams, study teams and manager
+ Manage CROs for non-clinical, TK/PK and clinical pharmacology related studies and activities by developing study timelines, objectives, and budgets, ensuring accuracy of project progress and completion and pro-actively identifying hurdles and providing solutions
+ Analyze and interpret PK/PD data generated during conduct of the non-clinical and clinical studies while communicating results and impact of results in a timely and effective manner to study teams and development sub-teams (under oversight of senior clinical pharmacology colleague)
+ Provide pharmacology input and collaborate with key cross functional team members such as clinical operations, clinical development, biostatistics, translational sciences, data management, medical writing, regulatory, and safety and therefore must possess good communication and interpersonal skills.
+ Complete all required organizational trainings and requirements according to corporate timelines and adhere to the appropriate SOP and GxP guidelines.
Knowledge Skills & Abilties
+ Contribute to non-clinical and clinical study designs, author functional sections of non-clinical and clinical study protocols, and finalizing non-clinical and clinical study reports
+ Lead internal pharmacology sub-team for early stage development
+ Align development plans with sub-teams, study teams and manager
+ Manage CROs for non-clinical, TK/PK and clinical pharmacology related studies and activities by developing study timelines, objectives, and budgets, ensuring accuracy of project progress and completion and pro-actively identifying hurdles and providing solutions
+ Analyze and interpret PK/PD data generated during conduct of the non-clinical and clinical studies while communicating results and impact of results in a timely and effective manner to study teams and development sub-teams (under oversight of senior clinical pharmacology colleague)
+ Provide pharmacology input and collaborate with key cross functional team members such as clinical operations, clinical development, biostatistics, translational sciences, data management, medical writing, regulatory, and safety and therefore must possess good communication and interpersonal skills.
+ Complete all required organizational trainings and requirements according to corporate timelines and adhere to the appropriate SOP and GxP guidelines.
Education
Doctoral degree (PhD or Equivalent training by experience [PharmD]) in clinical pharmacology, pharmacokinetics, pharmacology, toxicology, pharmaceutics, or relevant discipline.
Experience
From 5+ years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics, and other pharmacology components of non-clinical and early clinical trials within the pharmaceutical or biotech industry or academia.
Equivalency
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experie
