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Oruka Therapeutics · 3 hours ago

Senior Scientist, Clinical Pharmacology

United States

Full-time

Remote

Senior Level, Lead/Staff

$175K/yr - $200K/yr

8+ years exp

Oruka Therapeutics is a company focused on developing novel biologics for chronic skin diseases. They are seeking a Senior Scientist in Clinical Pharmacology to contribute to pharmacokinetic modeling and translational research efforts, aiming to develop best-in-class treatments for conditions like plaque psoriasis.

BiotechnologyHealth CareMedical

Responsibilities

Design and implement appropriate clinical modeling to contribute to successful clinical development plans and to drive rapid development

Author clinical pharmacology aspects of clinical study protocols, analysis plans, reports, and related regulatory and clinical documents

Perform non-compartmental analyses (NCA) of our clinical PK data

Influence the development of drugs and expand the application of model-informed drug development (MIDD) approaches across our portfolio. This will include the planning and execution of quantitative analyses which may include population pharmacokinetics and pharmacokinetics (PK)/pharmacodynamics (PD) exposure response

Engage with and manage outside vendors, partners and consultants as necessary, including oversight and review of PKPD analyses conducted by third party vendors

Support internal modeling and analysis outside of Clinical Pharmacology including working with Non-Clinical data and colleagues and supporting Corporate modeling efforts

Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships

Manage translational research efforts associated with clinical trial objectives by working with academic collaborators

You will partner with key stakeholders and colleagues including Development teams and leaders. You will interface closely with non-clinical scientists to facilitate modeling and data analysis in the non-clinical programs

Influence and lead the external environment through scientific societies, publications, presentations, and collaborations

Qualification

PharmacokineticsPharmacodynamicsPharmacometric modelingData analysisPhoenix WinNonlinR programmingSASNONMEMProject managementInterpersonal skillsCommunication skillsAttention to detail

Required

Bachelor's degree and 10 years of experience or master's degree and 8 years of experience in life sciences, pharmaceutical sciences, pharmacology with 8 years of experience in conducting clinical pharmacology studies including study design, PKPD data analysis, and interpretation of results

Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics)

Working knowledge of PKPD modelling approaches (including population PKPD approaches), bioanalysis, data analysis and biostatistics, programming, broad familiarity with the drug development process

Strong attention to detail with extensive experience reviewing and interpreting complex PK and PD data

Strong interpersonal skills, with the ability to work across cross-functional teams

Project management skills with sense of urgency, ability to collaborate and influence across teams

Demonstrated ability to work across functions including medical writing, clinical operations, biometrics, clinical development, quality and regulatory affairs

Excellent communication skills, both verbal and written, with the ability to convey complex data concepts to stakeholders at all levels