Associate Director – Clinical Pharmacology

Role Overview

• Design and implement appropriate PK/PD modeling to contribute to successful non-clinical/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 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 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 PK/PD analyses conducted by third party vendors.
• Support Corporate modeling efforts aligned with Oruka business development needs to broaden the Oruka pipeline and strategy.
• 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.
• 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.

Requirements

• 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.
• Key technical skills and experience
• 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.

Benefits

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.