Associate Director/Director, Clinical Pharmacology
New
O
Oruka TherapeuticsPharmaceuticals
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.Full-TimeDirector
Salary$182,000-$240,000 USD
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Job Details
- Experience
- Bachelor’s degree and 8 years of experience or advanced degree (PhD, PharmD, Masters) and 5 years of experience
- Required Skills
- R
Requirements
- Bachelor’s degree and 8 years of experience or advanced degree (PhD, PharmD, Masters) and 5 years of experience in pharmaceutical sciences/pharmacology
- 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.
- Extensive hands-on Phoenix WinNonlin/NLME experience
- 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
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.
- 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
- Partner with key stakeholders and colleagues including Development teams and leaders.
- Influence and lead the external environment through scientific societies, publications, presentations, and collaborations
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