Senior Clinical Pharmacology Lead
vor 3 Wochen
About the Position
Ridgeline Discovery GmbH is seeking a highly skilled Clinical Pharmacology Strategist to play a pivotal role in developing innovative therapies for obesity and cardiometabolic conditions.
Key Responsibilities
- Develop and implement clinical pharmacology strategies to support drug development programs.
- Collaborate with cross-functional teams to integrate pharmacokinetic (PK), pharmacodynamic (PD), and pharmacometrics analyses.
- Perform population PK/PD modeling, exposure-response analysis, and simulation to inform dose selection and study design.
- Contribute to the design of clinical trials, including first-in-human (FIH) and PoC studies, by providing input on dosing regimens, sample size, and study endpoints.
- Develop and review clinical study protocols, statistical analytic plans, and other related documents.
- Work closely with Regulatory to provide clinical pharmacology support for regulatory documents, communications, and presentations as needed.
Requirements
- Ph.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a related field.
- 10+ years of relevant experience in clinical pharmacology and pharmacometrics, with 5+ years in drug development in the pharmaceutical or biotechnology industry.
- Solid experience in PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection.
- Expert-level skills and expertise in PK/PD modeling and simulation activities, including NCA, population PK/PD modeling, literature meta-analyses, and exposure-response analyses.
- Proven track-record of working in a matrix environment, involving CROs, academic partners, and external expert consultants.
- Excellent oral and written communication skills, with high attention to critical details and the ability to collaborate effectively in cross-functional teams.
What We Offer
- An international and diverse team with talented and passionate people.
- An innovative and creative environment.
- Support for individual development and growth.
- A dynamic and entrepreneurial work environment.
- Commuter benefits and flexible working arrangements.
If you are a motivated and experienced Clinical Pharmacology Strategist looking to contribute to the development of innovative therapies, please submit your application, including your CV, cover letter, and reference letters.
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