Sr. Manager, Clinical Pharmacology

Location: Hybrid

Type: (Contract)

We have an exciting opportunity for a highly motivated and experienced Quantitative Clinical Pharmacologist to join our team within the Clinical Pharmacology, DMPK, and Bioanalysis department. Supporting programs in the CNS therapeutic area, this individual will serve as the Clinical Pharmacology Lead and act as a subject matter expert across cross-functional development teams.

This role has primary scientific responsibility for dose selection and optimization, integrating expertise across PK/PD, quantitative modeling and simulation, drug development, toxicokinetics, and nonclinical ADME/DMPK. The successful candidate will support multiple programs, collaborate closely with chemistry, biology, regulatory, and clinical operations, and influence strategy across the organization. Hands-on modeling experience is highly desirable.

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  Contribute to clinical program design, trial protocols, statistical analysis plans, clinical study reports, and regulatory submissions.

  
  
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  Conduct and oversee pharmacokinetic analyses (NCA), exposure-response assessments, simulation-based trial design, dose selection, and population clinical pharmacology modeling.

  
  
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  Present modeling strategies and defend model-based conclusions to internal governance bodies and regulatory agencies.

  
  
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  Write or review clinical pharmacology components for regulatory documents, responses, and participate directly in regulatory interactions.

  
  
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  Promote model-informed drug development through external collaborations, peer-reviewed publications, and conference presentations.

  
  
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  Function effectively within a highly matrixed, cross-functional environment.

  
  
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  Serve as an active scientific contributor and provide guidance to team members across integrated development programs.

  
  

Education & Experience

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  Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacometrics, or a related field.

  
  
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  3+ years (Ph.D.) or 4+ years (Pharm.D.) of clinical pharmacology experience in the pharmaceutical or biotechnology industry.

  
  
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  Demonstrated experience serving as a Clinical Pharmacology Lead on development programs.

  
  

Technical Expertise

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  Strong understanding of PK theory, compartmental modeling, simulation methodologies, and advanced quantitative approaches.

  
  
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  Hands-on programming experience with Phoenix is required; experience with Monolix, R, WinNonlin, SAS, or S-Plus is highly desirable.

  
  
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  In-depth knowledge of nonclinical and clinical DMPK processes.

  
  
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  Experience supporting small molecule programs and familiarity with CNS therapeutic development preferred.

  
  
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  Direct experience with PK/PD modeling, bioanalytical data interpretation, and nonclinical ADME is beneficial.

  
  

Regulatory & Writing Skills

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  Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology.

  
  
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  Prior direct interaction with FDA and experience contributing to IND, NDA, and CTD submissions is required.

  
  
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  Demonstrated experience in NCA, model-based PK/PD analyses, and incorporation of results into study reports, manuscripts, and regulatory documents.

  
  

Soft Skills

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  Excellent leadership, communication, collaboration, and time-management skills.

  
  
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  Proven ability to lead internal teams and oversee external vendors or outsourced modeling work.

  
  

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