Associate Director/Director, Clinical Pharmacology

About the role

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics for chronic skin diseases. As a key member of the Clinical Pharmacology team, this individual will design and implement PK/PD modeling, analyze nonclinical and clinical PK data, and develop PK/PD models using preclinical and clinical data.

Key Responsibilities

• Design and implement appropriate PK/PD modeling to contribute to successful non-clinical/clinical development plans and 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 non-clinical/clinical PK data including allometric scaling.
• Influence the development of drugs and expand the application of model-informed drug development (MIDD) approaches across the portfolio.
• Engage with and manage outside vendors, partners, and consultants, including oversight and review of PK/PD analyses conducted by third-party vendors.
• Support corporate modeling efforts aligned with Oruka business development needs to broaden the pipeline and strategy.
• Contribute to the development or improvement of tools, processes, and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia, and academic relationships.
• Partner with key stakeholders and colleagues including Development teams and leaders, interfacing closely with non-clinical scientists to facilitate modeling and data analysis in non-clinical programs.
• Influence and lead the external environment through scientific societies, publications, presentations, and collaborations.

Qualifications

• Bachelor’s degree and 8 years of experience or advanced degree (PhD, PharmD, Masters) and 5 years of experience in pharmaceutical sciences/pharmacology, conducting clinical pharmacology studies including study design, PK/PD data analysis, and interpretation of results. PhD/PharmD in Pharmaceutical Science, Math or related discipline preferred.
• Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics).
• Working knowledge of PK/PD modelling approaches (including population PK/PD approaches), bioanalysis, data analysis and biostatistics, programming, broad familiarity with the drug development process.
• Extensive hands-on Phoenix WinNonlin/NLME experience (NLME experience preferred).
• Additional experience in R, NONMEM, or other PK/PD data analysis or modeling platforms preferred.
• 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.

Compensation

An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. The anticipated salary range for candidates: Associate Director is $182,000-208,000 and for the Director is $213,000-240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.