Planet Pharma
Sr. Manager, Clinical Pharmacology
Planet Pharma, Waltham, Massachusetts, United States, 02254
Sr. Manager, Clinical Pharmacology – Planet Pharma
Pay commiserate with experience ranges between $85-95/hr.
Job Description We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
This position will have a core scientific responsibility of selecting optimal doses and dosage regimens inpatients, and will integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role will provide the opportunity to support multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable.
Essential Areas Of Responsibility
Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
Conducting and overseeing pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modelling
Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
Write or review clinical pharmacology components of regulatory documents and responses as well as participate directly in regulatory interactions
Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
Ability to function in a highly matrixed team environment
Requirements
Education: Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 3+ years or 4+ years of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs.
PK Experience: The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.
Knowledge: Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes.
Programming experience (Phoenix) is must; other programming experience (e.g., Monolix, R, WinNonlin, SAS, Splus) is desirable.
Regulatory: Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
Writing: Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents(e.g.: INDs, NDAs, CTDs) is required.
Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Job Description We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
This position will have a core scientific responsibility of selecting optimal doses and dosage regimens inpatients, and will integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role will provide the opportunity to support multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable.
Essential Areas Of Responsibility
Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
Conducting and overseeing pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modelling
Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
Write or review clinical pharmacology components of regulatory documents and responses as well as participate directly in regulatory interactions
Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
Ability to function in a highly matrixed team environment
Requirements
Education: Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 3+ years or 4+ years of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs.
PK Experience: The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.
Knowledge: Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes.
Programming experience (Phoenix) is must; other programming experience (e.g., Monolix, R, WinNonlin, SAS, Splus) is desirable.
Regulatory: Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
Writing: Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents(e.g.: INDs, NDAs, CTDs) is required.
Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr