Job Title: Associate Director/Director, Clinical Pharmacology

Location: Remote or Hybrid –If the employee is located within commutable distance of Waltham or Menlo Park, the employee is required to work from the applicable company physical office, currently three days per week. If not located within commutable distance of Waltham or Menlo Park, the employee is not required to work from a Company physical office on a scheduled basis.

Role Overview:

As a key member of the Clinical Pharmacology team, this individual will be responsible for pharmacokinetic modeling, analyzing nonclinical and clinical PK data using non-compartmental analysis, and exploring exposure/response relationships using data from our clinical and non-clinical development programs. In addition, the role will be integral to developing PK/PD models using preclinical and clinical data to assess Oruka’s strategic emphasis on creating best in class treatments.

Key Responsibilities:

• 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

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.
• 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.

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.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.