Assoc Dir Clinical Pharmacology - Jersey City
1 day ago
Job description
The Associate Director, Clinical Pharmacology provides scientific and technical expertise across all aspects of Clinical Pharmacology and model-informed drug development, including study planning, pharmacokinetic (PK) and PK/PD analysis, modeling and simulation, and regulatory documentation to support early- and late-stage clinical development.
This role works cross-functionally with regulatory affairs, clinical operations, project management, data management, biostatistics, and external partners to ensure clinical pharmacology deliverables are aligned with regulatory expectations and internal standard operating procedures (SOPs).
The Associate Director contributes to the interpretation of clinical pharmacology data and authors or reviews documents for submission to regulatory agencies, including the U.S.
Food and Drug Administration (FDA).
Assignment to this level is based on depth of scientific expertise, years of experience, complexity of responsibilities, and demonstrated impact on project teams and development programs.
Provide clinical pharmacology and pharmacometrics expertise to cross-functional development teams and support the design, execution, and interpretation of clinical pharmacology studies across multiple stages of development.
Contribute to dose selection and optimization, dosing regimens (including special populations), and key elements of study design in collaboration with pharmacometrics, biostatistics, and clinical colleagues.
Perform and/or oversee non-compartmental and compartmental analyses of clinical PK data and interpret PK and PK/PD results. Ensure the use of validated bioanalytical methods for drug and biomarker measurement. Experience with WinNonlin is required.Work with external bioanalytical laboratories to develop and validate appropriate methods to support PK/ADME analyses, and review bioanalytical validation reports
Good understanding of model-based development and interpretation of modeling and simulation approaches, including population PK, PK/PD modeling, and clinical trial simulations, to support dose selection and study design.
Experience with NONMEM/R is preferred but not required.Collaborate closely with internal team members, Contract Research Organizations (CROs), partner organizations, and management to ensure high-quality and timely clinical pharmacology deliverables.
Make meaningful contributions to clinical pharmacology and pharmacometrics strategies to support scientific, regulatory, and development objectives within assigned programs.Prepare, review, and contribute to regulatory documents, including clinical study reports, protocols, investigator brochures, FDA briefing documents, responses to regulatory questions, presentations, abstracts, and other scientific materials.
Support responses to regulatory agency inquiries related to clinical pharmacology.Maintain awareness of emerging scientific literature, regulatory guidance, and advances in clinical pharmacology and pharmacometrics, incorporating innovative approaches into study design and life-cycle management strategies where appropriate.
Support the evaluation of compounds proposed for incorporation into transdermal systems or other formulations. Experience with transdermal drug development is preferred but not required.May collaborate with business development and cross-functional teams in the scientific assessment of potential in-licensing opportunities.
Qualifications
Education / Experience
Ph.
D. in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, or a related discipline.
Minimum of 5 years of relevant experience in clinical pharmacology and/or pharmacometrics within a pharmaceutical or biotechnology R&D environment.
Solid working knowledge of FDA, ICH, and CFR regulations and clinical pharmacology-related guidance documents.
Competencies
Demonstrated ability to work independently while contributing effectively to cross-functional teams.
Strong analytical, problem-solving, and scientific writing skills.
Ability to influence program strategy through data-driven recommendations.
May provide scientific guidance, mentoring, or functional leadership to junior staff or project team members, without direct line management responsibility.
Judgment / Decision MakingApplies sound scientific judgment to moderately complex clinical pharmacology issues.
Contributes to project-level strategies and recommendations that impact study design, dosing rationale, and regulatory interactions.
Identifies opportunities for improved methodologies, modeling approaches, and efficiencies within clinical pharmacology deliverables.
Work Environment
Primarily office-based with extensive computer use.
This position follows a hybrid work model and requires a minimum of two days per week working on-site in the office.
Physical DemandsRequires visual acuity and manual dexterity for computer operation, data review, and document preparation.
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