Advantage Technical
Senior Quantitative Clinical Pharmacologist
Department:
Clinical Pharmacology, DMPK & Bioanalysis
Pay rate up to $95/hr
Position Overview We are seeking a highly motivated and experienced Quantitative Clinical Pharmacologist to support programs within the CNS therapeutic area. As a key member of the Clinical Pharmacology, DMPK, and BA organization, this individual will serve as the Clinical Pharmacology Lead, providing subject matter expertise across cross‑functional development teams.
This role carries core scientific responsibility for dose selection and optimization, integrating PK/PD principles, quantitative modeling and simulation, drug development knowledge, toxicokinetics, and nonclinical PK (ADME/DMPK). The position offers the opportunity to contribute to multiple programs and collaborate closely with chemistry, life sciences, regulatory, and clinical operations teams. Hands‑on modeling experience is highly desirable.
Key Responsibilities
Contribute to clinical program design, protocol development, analysis plans, study reports, and regulatory submissions.
Conduct and oversee pharmacokinetic (noncompartmental) analyses.
Simulation‑based trial design and dose selection.
Population PK/PD and clinical pharmacology modeling.
Present modeling strategies and defend model‑based conclusions to internal governance boards and regulatory agencies.
Write or review clinical pharmacology sections of regulatory documents and participate directly in regulatory interactions.
Scientific Leadership & Collaboration
Promote model‑informed drug development through external collaborations, publications, and conference presentations.
Function effectively within a highly matrixed team environment.
Provide innovative scientific input to multidisciplinary project teams and guide team members as needed.
Serve as a liaison between chemistry, life sciences, regulatory, and clinical operations.
Technical Expertise
Apply strong knowledge of clinical pharmacology, PK/PD modeling, bioanalysis, and nonclinical ADME.
Contribute to CNS therapeutic programs with an understanding of disease‑specific pharmacology.
Act independently after onboarding, providing sound scientific recommendations to project teams.
Requirements Education & Experience
Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacometrics, or related field.
3+ years (Ph.D.) or 4+ years (Pharm.D.) of industry experience in clinical pharmacology.
Demonstrated experience serving as a Clinical Pharmacology Lead on development programs.
Technical Skills
Strong understanding of pharmacokinetic theory, compartmental modeling, simulation, and statistical approaches.
Required: Proficiency with Phoenix.
Preferred: Experience with Monolix, R, WinNonlin, SAS, S‑Plus, or similar tools.
Solid working knowledge of nonclinical and clinical DMPK processes and cross‑functional interfaces.
Regulatory Expertise
Current knowledge of FDA guidance related to nonclinical and clinical pharmacology.
Direct experience interacting with FDA and contributing to IND, NDA, and other regulatory submissions.
Experience preparing PK and PK/PD analyses for manuscripts, study reports, and regulatory documents (INDs, NDAs, CTDs).
Soft Skills
Excellent interpersonal, leadership, communication, and time‑management skills.
Demonstrated ability to manage internal and external (outsourced) personnel.
Ability to thrive in a fast‑paced, matrixed environment and drive scientific decision‑making.
Seniority level Mid‑Senior level
Employment type Contract
Job function Research
Pharmaceutical Manufacturing
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Clinical Pharmacology, DMPK & Bioanalysis
Pay rate up to $95/hr
Position Overview We are seeking a highly motivated and experienced Quantitative Clinical Pharmacologist to support programs within the CNS therapeutic area. As a key member of the Clinical Pharmacology, DMPK, and BA organization, this individual will serve as the Clinical Pharmacology Lead, providing subject matter expertise across cross‑functional development teams.
This role carries core scientific responsibility for dose selection and optimization, integrating PK/PD principles, quantitative modeling and simulation, drug development knowledge, toxicokinetics, and nonclinical PK (ADME/DMPK). The position offers the opportunity to contribute to multiple programs and collaborate closely with chemistry, life sciences, regulatory, and clinical operations teams. Hands‑on modeling experience is highly desirable.
Key Responsibilities
Contribute to clinical program design, protocol development, analysis plans, study reports, and regulatory submissions.
Conduct and oversee pharmacokinetic (noncompartmental) analyses.
Simulation‑based trial design and dose selection.
Population PK/PD and clinical pharmacology modeling.
Present modeling strategies and defend model‑based conclusions to internal governance boards and regulatory agencies.
Write or review clinical pharmacology sections of regulatory documents and participate directly in regulatory interactions.
Scientific Leadership & Collaboration
Promote model‑informed drug development through external collaborations, publications, and conference presentations.
Function effectively within a highly matrixed team environment.
Provide innovative scientific input to multidisciplinary project teams and guide team members as needed.
Serve as a liaison between chemistry, life sciences, regulatory, and clinical operations.
Technical Expertise
Apply strong knowledge of clinical pharmacology, PK/PD modeling, bioanalysis, and nonclinical ADME.
Contribute to CNS therapeutic programs with an understanding of disease‑specific pharmacology.
Act independently after onboarding, providing sound scientific recommendations to project teams.
Requirements Education & Experience
Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacometrics, or related field.
3+ years (Ph.D.) or 4+ years (Pharm.D.) of industry experience in clinical pharmacology.
Demonstrated experience serving as a Clinical Pharmacology Lead on development programs.
Technical Skills
Strong understanding of pharmacokinetic theory, compartmental modeling, simulation, and statistical approaches.
Required: Proficiency with Phoenix.
Preferred: Experience with Monolix, R, WinNonlin, SAS, S‑Plus, or similar tools.
Solid working knowledge of nonclinical and clinical DMPK processes and cross‑functional interfaces.
Regulatory Expertise
Current knowledge of FDA guidance related to nonclinical and clinical pharmacology.
Direct experience interacting with FDA and contributing to IND, NDA, and other regulatory submissions.
Experience preparing PK and PK/PD analyses for manuscripts, study reports, and regulatory documents (INDs, NDAs, CTDs).
Soft Skills
Excellent interpersonal, leadership, communication, and time‑management skills.
Demonstrated ability to manage internal and external (outsourced) personnel.
Ability to thrive in a fast‑paced, matrixed environment and drive scientific decision‑making.
Seniority level Mid‑Senior level
Employment type Contract
Job function Research
Pharmaceutical Manufacturing
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