Senior Clinical Pharmacology Strategist

vor 1 Monat

Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH Vollzeit
Job Title: Senior Clinical Pharmacology Strategist

SixPeaks Bio, a biotechnology enterprise, is seeking a Senior Clinical Pharmacology Strategist to join our team. As a key member of our development team, you will play a pivotal role in advancing our pipeline of antibody-based compounds targeting obesity and associated co-morbidities.

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 of regulatory documents, communications, and presentations as needed.
Qualifications:
  • 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 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.
  • Proven track-record of working in a matrix environment, involving CROs, academic partners, and external expert consultants.
Personal Qualities:
  • Highly motivated self-starter with a can-do attitude and passion for working in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment.
  • Proven ability to build, maintain, and influence effective working relationships with key internal and external stakeholders.
  • Good planning skills and strength in delivering outputs on agreed timelines.
What We Offer:
  • A dynamic and innovative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.
  • A collaborative and supportive team environment.

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