Clinical Pharmacology and Pharmacometrics Lead at ATR Profile

Job Title: Project Consultant/ Clinical Pharmacology & Pharmacometrics Lead
This is a contract position with an expected duration of 12 months w/ potential extension
Must be authorized to work in the US

One of our premier clients is seeking a Clinical Pharmacology and

Pharmacometrics Lead. This contractor will be reporting to the Head

of Clinical Pharmacology and Pharmacometrics (CP&P), the Clinical

Pharmacology and Pharmacometrics Lead (CP&P Lead) will lead the
development of computational approaches to address high priority project
development efforts at the Institute. The CP&P Lead will work with
project teams to implement and communicate model-informed drug
development strategies, to enable and accelerate internal decisions. The
CP&P Lead will develop and build a diverse set of approaches to tackling
discovery and development questions across the pipeline, including PK
and PK-PD, QSP, PBPK, and data science approaches. This contractor will
build partnerships with academic and CRO partners to facilitate the
development of fit for purpose computational models. The candidate will
also collaborate with DMPK, Biostats, Clinical development, discovery,
and other functional groups across the organization to deliver on
quantitative sciences objectives. This contractor will lead technology
initiatives geared towards enabling a robust simulation platform, based
on well-calibrated models, constrained by diverse data streams, and
advanced approaches in developing virtual patient populations
commensurate to simulating clinical scenarios of interest. The candidate
will ensure alignment of client values and innovate culture with our
talent strategy and programs.

Responsibilities include but are not limited to:
- Provide strategic leadership in CP&P for both late-stage and

early-stage assets, particularly in infectious diseases with focus

on Tuberculosis and Malaria.
- Develop advanced models of drug exposure, exposure-biomarker
response, and disease progression to facilitate informed drug
development decisions.
- Collaborate extensively with internal and external stakeholders
across various therapeutic areas, offering expertise in modeling,
data science, visualization, and data analytics.
- Act as a Study Director and Clinical PK Scientist for infectious
diseases programs.
- Contribute to regulatory documents related to Clinical Pharmacology,
draft sections for clinical development plans, and engage in
regulatory interactions.
- Assess the feasibility of clinical studies, providing critical input
on the design and review of clinical protocols.
- Execute and manage Pharmacometrics and Modeling & Simulation (M&S)
plans, interpreting and reporting results to support clinical
development milestones.
- Integrate data from various compounds across development programs to
inform strategic portfolio decisions.
- Represent the department in cross-functional teams, proactively
addressing development opportunities.
- Lead cross-functional teams covering multiple assets, mentor junior
Clinical Pharmacology scientists, and promote a culture of
scientific excellence and innovation.
- Support project milestones in discovery and development phases using
mathematical modeling and simulation tools, including PK/PK-PD,
drug-drug interaction evaluation, PBPK-based dose/exposure scaling,
QSP, and formulation/PK assessment.
- Utilize advanced data analysis techniques and develop algorithms to
detect patterns and associations in data, leveraging diverse
datasets to inform models relevant to disease biology.

Qualifications
- PhD in engineering, math, computer science, pharmaceutical sciences
or a related quantitative field
- 10+ years experience working in a quantitative discipline, demonstrated

impact in PK-PD, QSP, PBPK, disease progression, DMPK modeling.
-Proficient high performance computing skills
- Excellent communication and written skills, distilling complex
technical ideas clearly and succinctly to a diverse audience.
- Ability to multi-task and manage through competing priorities in a
fast-paced environment
- Ability to work independently and within a team environment.
- Strong attention to detail and high sense of urgency
- Demonstrated ability of leveraging self-initiative to get results
- Strong analytical, organizational and auditing skills required
- Demonstrated passion for the Gates MRI’s values with a commitment to
deliver results against our mission.
- Expertise in developing and applying PK, PBPB, and PKPD models using
software such as Matlab, R, NONMEM, Monolix, SimCYP, PK-SIM,
GastroPlus, Phoenix, and R-Stan.
- Experienced in designing, implementing, and maintaining a
GXP-validated high-performance pharmacometrics scientific
computational environment.
- Experienced in compiling and optimizing diverse data sets from both
clinical and non-clinical sources to enhance Model-Informed Drug
Development (MIDD) efficiency.

Arena Technical Resources, LLC, (ATR) is an Equal Opportunity Employer
(EOE) who will provide equal employment opportunity to employees and
applicants for employment without regard to race, ethnicity, religion,
color, sex, pregnancy, national origin, age, veteran status, ancestry,
sexual orientation, gender identity or expression, marital status,
family structure, genetic information, or mental or physical disability.