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Senior Quantitative Pharmacologist

TN United Kingdom

Cambridge

On-site

GBP 100,000 - 125,000

13 days ago

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Job summary

An established industry player is seeking a Senior Quantitative Pharmacologist to drive impactful analyses in drug development. This role involves executing complex pharmacokinetic and pharmacodynamic studies while collaborating with cross-functional teams to prepare critical regulatory documents. The ideal candidate will have a PhD and extensive experience in quantitative methods, making independent decisions to ensure project success. Join a forward-thinking organization that values data intimacy and offers the opportunity to contribute significantly to innovative programs. If you are passionate about pharmacology and ready to take on challenges, this position is for you.

Qualifications

  • Minimum PhD with 3+ years of relevant experience in quantitative pharmacology.
  • Advanced understanding of statistical methods applicable to clinical trials.

Responsibilities

  • Conduct PK/PD analyses and prepare regulatory submission documents.
  • Collaborate with teams to deliver PMx results and documentation.

Skills

Quantitative Analysis

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Statistical Methods

Communication Skills

Education

PhD in relevant field

Tools

Non-compartmental analysis methods

Compartmental modeling

Bayesian approaches

Job description

Senior Quantitative Pharmacologist, Cambridge
Client:
Location:

Cambridge, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

068e8858d9c0

Job Views:

115

Posted:

24.03.2025

Expiry Date:

08.05.2025

Job Description:

We are looking for a Senior Quantitative Pharmacologist to provide significant contributions in support of multiple programs. The person in this role is responsible for the execution of PK, PD, and other types of quantitative analyses that significantly contribute to the development of these programs. The Senior Scientist should work collaboratively across the organization to evaluate, design, select, and apply standardized scientific techniques to analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies. We need this person for the preparation and timely delivery of accurate and well-articulated nonclinical or clinical study reports, and regulatory submission documents.

A typical day in the life of a Senior Quantitative Pharmacologist may look like:

  1. In collaboration with other team members and modest supervision, plans, designs, implements, and analyzes results for a variety of PMx studies. Performing a broad array of quantitative PK or PK/PD analyses such as but not limited to NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E-R analyses (or in close collaboration with Research Specialist or PMx Stats Programming team) to deliver PMx results. Works with supervision to develop interpretation and discussion of results.
  2. Works collaboratively with PMx Research Specialists, PMx Programming Team, Scientific Writers, and/or other contributors to prepare TFLs in support of a number of internal or regulatory documents such as PK/PD study reports, IND/CTA, summary modules CSR, IB, etc. Works in conjunction with Scientific Writing, QC and QAA (as required) to complete final draft documentation in support of IND/CTA submissions and other regulatory documents.
  3. With mentorship from senior PMx staff, supports preparation of material to be used in regulatory interactions. Prepares PMx materials for regulatory background packages, e.g., for pre-IND, EOP2, and pre-BLA meetings. Performs additional analyses as required to support regulatory interactions.

This may be the right role for you if:

  1. You have excellent interpersonal and communication skills both written and oral and ability to function independently.
  2. Familiarity with regulatory/research guidelines on drug development (e.g., ICH and GxP guidelines).
  3. Want to work in an organization where data intimacy is valued.
  4. You are looking to make decisions independently for assigned studies or indication while proactively seeking line management intervention where needed to ensure successful outcomes.

In order to be considered qualified, you must:

Have a minimum of a PhD and 3+ years of relevant experience. Experience should include an advanced understanding of quantitative concepts and techniques, including: non-compartmental analysis methods, compartmental modeling, translational modelling/pharmacology, Exposure-Responses analysis methods, Nonlinear Mixed Effects modeling, disease modelling/QSP.

We expect experience with advanced PMx statistical methods and the applicability to clinical trials: such as survival analysis, stratified or covariate analyses and strategies for handling missing data, logistic regression, survival analysis, Bayesian approaches.

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Created on 24/03/2025 by TN United Kingdom

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