Associate Director/Director, Clinical Pharmacology
About the role
About Us
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
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 d