Principal Clinical Pharmacologist

As a Principal Clinical Pharmacologist, this individual is expected to plan, design, implement and analyze invivo and in-vitro pharmacokinetic & pharmacodynamic studies working with CP, QP, PPKPD,
Toxicology, Bioanalytical, Therapeutic Focus areas and Clinical Development / Regulatory
Affairs.

This individual contributes to the scientific understanding of PK/PD for assigned projects,
based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for
research programs, through the application of state-of-the-art knowledge in pharmacokinetics
and pharmacodynamics.

Responsibilities

• Plans, designs, implements and analyzes routine PMx studies to advance scientific
knowledge, in collaboration with other team members.
• Performs analyses such as NCA, compartmental modeling, PopPK, translational
modelling, disease modelling, Pop PK/PD, E-R analyses (or work closely with Research
Specialist or PMx Stats Programming team) to deliver PMx results, interpretation and
discussion. Contributes tables and figures for management presentations. Monitors and
evaluates completion of tasks and projects.
• Contributes to Research or GCST study team meetings.
• Works (or collaborates with Research Specialist or Programming team) to prepare TFLs
to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other
documents. Collaborates with Scientific Writing (and where appropriate with PMx Stats
Programming team) to ensure TFLs for PMx reports are complete. Works in conjunction
with Scientific Writing, QC and QAA (as required) to issue study reports in support of
IND/CTA submissions and other regulatory documents.
• With close supervision from senior PMx staff, supports preparation of material to be
used in regulatory interactions. Contributes to preparation of 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.
• Participates in technical working groups, providing support for process improvement
initiatives.
• Actively publishes work in scientific literature

Knowledge and Skills
• Has understanding of advanced PMx concepts and techniques, such as advanced
pharmacokinetics, advanced pharmacological principles, non-compartmental analysis
methods, Exposure-Response analysis methods, translational modelling/pharmacology,
Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian
approaches, disease modelling/QSP.
• Has knowledge of advanced PMx methodologies applicable to clinical trials, such as
survival analysis, stratified or covariate analyses, and strategies for handling missing
data.
• Has familiarity with regulatory/research guidelines on drug development, GxP, and
statistical principles (especially ICH guidelines)
• Is able to clearly describe advanced PMx techniques and interpret results.
• Is able to formulate PMx objectives, design, and analyses for complex clinical projects
• Is able to meet timelines for deliverables such as topline results and final analyses.
• Has good communication & negotiation skills and is able to manage internal team and
CROs.
• Is highly skilled in use of relevant software, including MS-Excel, R, R-Studio, Prism,
Phoenix WinNonlin, NLME, STAN and NonMem, working in department computing
environment to perform advanced PMx analyses.

Job Complexity
- Shows independence and ability to initiate activities on own.
- Is able to serve independently as study CP/QP/PPKPD lead for moderately complex
studies or support study CP/QP/PPKPD lead for more complex studies, and to
contribute to or lead non-project objectives.
- Is able to make moderately complex decisions for assigned studies, and knows when to
seek guidance on decision making.
- Is able to communicate effectively with and influence team members from other
functions.
- Fully understands processes and is able to represent PMx on process initiatives.
- Is beginning to establish own research areas within development sciences.