Associate Director/Director, Clinical Pharmacology

About the role

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. For more information, visit www.orukatx.com 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.

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
• 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

• 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 abi

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