Clinical Pharmacologist

Advantage Technical; Waltham (MA); Híbrido; USD 130 872; Tempo integral

Resumo da oferta

A leading clinical research organization is seeking a highly motivated quantitative clinical pharmacologist to serve as the Clinical Pharmacology Lead. This role involves significant collaboration, providing expertise in dose selection through PK/PD modeling, and ensuring regulatory compliance. The ideal candidate will have a Ph.D. or Pharm.D., 3+ years of experience, and a strong understanding of CNS therapeutics. This position allows for hybrid work, requiring in-office attendance three days a week in Waltham, MA and offers competitive compensation.

Qualificações

• 3+ years of industry experience as Clinical Pharmacology Lead.
• Experience with small-molecule CNS therapeutics preferred.
• Proven ability in preparing regulatory submissions and documentation.

Responsabilidades

• Contribute to clinical program design and study protocols.
• Conduct PK analyses and population PK/PD modeling.
• Present models and interpretations to regulatory authorities.
• Author or review regulatory documents like INDs and NDAs.

Conhecimentos

Quantitative modeling

Pharmacokinetics

Pharmacodynamics

Regulatory documentation

Team leadership

Formação académica

Ph.D. or Pharm.D. in Pharmaceutical Sciences

Ferramentas

Phoenix

Monolix

R

WinNonlin

SAS

Descrição da oferta de emprego

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.