Talent Groups ยท 21 hours ago
Clinical Pharmacologist
United States
Contract
Remote
Mid, Senior Level
$80/hr - $85/hr
3+ years expTalent Groups is seeking a Clinical Pharmacologist with extensive experience in the pharmaceutical industry. The role involves leading clinical pharmacology development programs, applying pharmacokinetic theory, and ensuring compliance with FDA regulatory guidance.
IT Management
Hiring Manager
Pravalika Kodupuganti
Responsibilities
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
Qualification
Required
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
Strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools
Sound working knowledge of the cross-function interfaces that are important for efficient drug development
Detailed understanding of non-clinical and clinical DMPK processes
Programming experience (Phoenix) is must
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
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)
Excellent interpersonal, leadership, communication and time-management skills
Demonstrated direct management of internal and external personnel (outsourced projects)
Preferred
Other programming experience (e.g., Monolix, R, WinNonlin, SAS, Splus) is desirable
Company
Talent Groups
Talent Groups delivers exceptional experiences by solving the toughest IT talent and technology challenges across all industries.
501-1000 employees
H1B Sponsorship
Talent Groups has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2018-07-01Acquired
Leadership Team
Matthew James Ripaldi
Chief Executive Officer
Recent News
2024-05-20
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