Job Title: Clinical Scientist, Clinical Pharmacology

Location: Remote-United States OR Hybrid in Menlo Park, CA -or- Waltham, MA

Key Responsibilities: As a key member of the Clinical Pharmacology team, this individual will be responsible for pharmacokinetic modeling , analyzing clinical PK data using non-compartmental analysis, engaging in translational research efforts and exploring exposure/response relationships using data from our clinical and non-clinical development programs. In addition, the role will be integral to developing effective models using preclinical and clinical data to assess Oruka’s strategic emphasis on creating best in class treatments. Furthermore, this role will likely include responsibilities for developing and executing translational plans beyond pharmacokinetics. As such, you will

• 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

Qualifications:

• 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. PhD in Pharmaceutical Science, Math or related discipline preferred.
• 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.
• Extensive hands-on Phoenix WinNonlin experience, R, SAS, NONMEM, or other PKPD 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, is $175,000 to $ 200,000. 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.

Job Location:

• Position may be remote, if the candidate lives near one of our offices in either Menlo Park, CA or Waltham, MA, candidates will be required to be in-office in 3 days/week.