Freelance Clinical Pharmacology Manager Start: ASAP * Workload: Part‑timeto Full-time/remote * Industry: Pharma/Biotech We are seeking an experienced Freelance Clinical Pharmacology Expert to support our clients NDA/MAA preparation and provide scientific leadership across development activities. Required Qualifications Medical degree or advanced scientific degree (clinical pharmacology, toxicology, PK/PD, etc.) Strong experience in PK/PD and clinical pharmacology assessments Background in biotech/pharma ; Phase 1 experience is a plus Proven track record preparing clinical pharmacology documents for NDA/MAA Experience interacting with regulatory agencies Strong project management and excellent English Proactive, hands‑on, structured, able to work independently and in teams Key Responsibilities Act as subject matter expert for PK, metabolism, and DDIs Identify clinical pharmacology risks and mitigation strategies Provide input to NDA/MAA strategies Summarize and interpret in vitro ADME, in vivo PK, and human PK/ADME/DDI data Collaborate on mechanistic PK/PD models Prepare/Review: DMPK and Clinical Pharmacology sections of IND/CTA/NDA/MAA Study protocols, reports, clinical development plans Support responses to regulatory authority questions If you are an experienced freelancer ready to contribute to a key regulatory milestone, we look forward to hearing from you! ClinicalPharmacology ClinicalPharmacologist PKPD Pharmacokinetics Pharmacodynamics ADME DMPK DrugDevelopment RegulatoryAffairs NDA MAA BiotechJobs PharmaFreelance FreelanceExpert ClinicalResearch Phase1Studies MedicalScience PharmaConsultant RemoteFreelance LifeScienceJobs SThree_Germany is acting as an Employment Business in relation to this vacancy.