Senior Clinical Pharmacology Strategist
vor 2 Monaten
Ridgeline Discovery GmbH is a biotechnology enterprise focused on advancing innovative therapies for the treatment of obesity and cardiometabolic conditions.
Job Title: Senior Clinical Pharmacology StrategistWe are seeking a highly motivated and experienced Senior Clinical Pharmacology Strategist to join our team. As a key member of our drug development team, you will be responsible for developing clinical pharmacology strategies to support the advancement of our pipeline.
Key Responsibilities:- Develop and Implement Clinical Pharmacology Strategies: Collaborate with cross-functional teams to integrate pharmacokinetic (PK), pharmacodynamic (PD), and pharmacometrics analyses to support drug development programs.
- Subject Matter Expertise: Serve as a clinical pharmacology subject matter expert and advisor to senior management, providing input on dosing regimens, sample size, and study endpoints.
- PK/PD Modeling: Perform population PK/PD modeling, exposure-response analysis, and simulation to inform dose selection and study design, utilizing modeling and simulation tools to support decision-making.
- Study Design and Protocol Development: 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, and develop and review clinical study protocols, statistical analytic plans, and other related documents.
- Data Analysis and Interpretation: Analyze clinical PK/PD data and interpret the results to understand the pharmacological profile of the investigational drug, contributing to the preparation of Clinical Study Reports, the Investigator Brochure, and scientific publications.
- Regulatory Submissions/Interactions: Work closely with Regulatory to provide clinical pharmacology support of regulatory documents, communications, and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summary sections, or addressing review inquiries).
- 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 of experience within the context of drug development in the pharmaceutical or biotechnology industry.
- Solid Experience: In the context of PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection.
- Expert Level Skills: In PK/PD modeling and simulation activities (NCA, population PK/PD modeling, literature meta-analyses, exposure-response analyses).
- Proven Track-Record: Of working in a matrix environment, involving CROs, academic partners, and external expert consultants.
- Excellent Communication Skills: With high attention to critical details and proven ability to collaborate effectively in cross-functional teams and influence decision-making processes.
- 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.
- Able to Work: Both independently and as part of a team.
This is an exciting opportunity to join a dynamic and innovative team, working on cutting-edge therapies for the treatment of obesity and cardiometabolic conditions. As a Senior Clinical Pharmacology Strategist, you will have the opportunity to contribute to the development of our pipeline and make a meaningful impact on the lives of patients.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.
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