Advantage Technical
Location: Hybrid (3 days/week onsite in Waltham, MA)
Pay Rate: $95/hour
Job Type: Long Term Contact
We are seeking a highly motivated and experienced quantitative clinical pharmacologist to join our Clinical Pharmacology, DMPK, and Bioanalysis (BA) department supporting CNS therapeutic programs. The Sr. Manager will serve as the Clinical Pharmacology Lead, providing subject matter expertise and strategic guidance to cross‑functional project teams. This role is central to dose and regimen selection, leveraging PK/PD principles, quantitative modeling and simulation, drug development knowledge, and nonclinical PK (ADME/DMPK). Hands‑on modeling experience is strongly preferred.
This position supports multiple programs, collaborating closely with chemistry, life sciences, regulatory, and clinical operations while functioning independently within a highly matrixed organization.
Key Responsibilities
Contribute to clinical program design, study protocols, data analysis plans, study reports, and regulatory submissions.
Conduct and oversee PK analyses (including NCA), exposure–response modeling, population PK/PD modeling, and simulation‑based trial design to inform dose selection.
Present modeling strategies, data interpretations, and recommendations to internal governance committees and regulatory authorities.
Author or review clinical pharmacology sections of regulatory documents (INDs, NDAs, CTDs) and support direct regulatory interactions.
Promote model‑informed drug development through external collaborations, publications, and scientific conference presentations.
Operate effectively in a highly matrixed team environment and contribute scientific leadership across multidisciplinary teams.
Provide innovative scientific input and offer guidance to other team members as appropriate.
Qualifications Education & Experience
Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacokinetics/Pharmacometrics, or a related field.
3+ years of industry experience with demonstrated leadership as a Clinical Pharmacology Lead on development programs.
Background in clinical pharmacology, pharmacokinetics, PK/PD modeling, and bioanalytical sciences; experience with small‑molecule CNS therapeutics preferred.
Technical Expertise
Strong understanding of PK theory, compartmental modeling, simulation methodologies, and advanced quantitative analysis.
Hands‑on programming experience is required (Phoenix is preferred).
Additional experience with tools such as Monolix, R, WinNonlin, SAS, or S‑Plus is desirable.
Thorough understanding of nonclinical and clinical DMPK workflows and cross‑functional drug development processes.
Regulatory Experience
Knowledge of FDA guidance related to nonclinical and clinical pharmacology.
Experience preparing and submitting IND, NDA, and other regulatory documentation, including direct interaction with the FDA.
Writing & Communication
Proven ability to prepare noncompartmental and model‑based PK/PD analyses for manuscripts, study reports, and regulatory submission components.
Excellent interpersonal, leadership, communication, and time‑management skills.
Experience managing internal and external partners, including outsourced project oversight.
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This position supports multiple programs, collaborating closely with chemistry, life sciences, regulatory, and clinical operations while functioning independently within a highly matrixed organization.
Key Responsibilities
Contribute to clinical program design, study protocols, data analysis plans, study reports, and regulatory submissions.
Conduct and oversee PK analyses (including NCA), exposure–response modeling, population PK/PD modeling, and simulation‑based trial design to inform dose selection.
Present modeling strategies, data interpretations, and recommendations to internal governance committees and regulatory authorities.
Author or review clinical pharmacology sections of regulatory documents (INDs, NDAs, CTDs) and support direct regulatory interactions.
Promote model‑informed drug development through external collaborations, publications, and scientific conference presentations.
Operate effectively in a highly matrixed team environment and contribute scientific leadership across multidisciplinary teams.
Provide innovative scientific input and offer guidance to other team members as appropriate.
Qualifications Education & Experience
Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacokinetics/Pharmacometrics, or a related field.
3+ years of industry experience with demonstrated leadership as a Clinical Pharmacology Lead on development programs.
Background in clinical pharmacology, pharmacokinetics, PK/PD modeling, and bioanalytical sciences; experience with small‑molecule CNS therapeutics preferred.
Technical Expertise
Strong understanding of PK theory, compartmental modeling, simulation methodologies, and advanced quantitative analysis.
Hands‑on programming experience is required (Phoenix is preferred).
Additional experience with tools such as Monolix, R, WinNonlin, SAS, or S‑Plus is desirable.
Thorough understanding of nonclinical and clinical DMPK workflows and cross‑functional drug development processes.
Regulatory Experience
Knowledge of FDA guidance related to nonclinical and clinical pharmacology.
Experience preparing and submitting IND, NDA, and other regulatory documentation, including direct interaction with the FDA.
Writing & Communication
Proven ability to prepare noncompartmental and model‑based PK/PD analyses for manuscripts, study reports, and regulatory submission components.
Excellent interpersonal, leadership, communication, and time‑management skills.
Experience managing internal and external partners, including outsourced project oversight.
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