PK/PD Module expert: Translational
vor 10 Stunden
The client is seeking an external expert who brings a decision-maker’s mindset — someone who has personally driven translational pharmacology choices under governance and uncertainty. Who we’re looking for Has owned FIH starting dose, SAD/MAD design, and Phase 2 dose selection for multiple assets. Participated in governance or review boards, defending dose/exposure rationale in front of senior leadership or regulators. Demonstrates ability to balance nonclinical → clinical translation: tox, PK, PD, potency, and MoA. Can articulate the real decision calculus behind dose selection (safety, pharmacology, speed-to-proof). Capable of turning narrative judgment into explicit decision rules and rubrics for AI training and evaluation. Experience level ~10+ years in major biopharma or biotech (e.g., Lilly, Roche, AbbVie, Amgen, Novartis, GSK, Regeneron, Vertex, Incyte, Gilead) or in specialized translational pharmacology consulting. Has personally led FIH dose and/or SAD/MAD escalation for ≥2–3 assets. Proven governance experience: IND sign-off, dose justification memos, exposure–response presentations. CV or track record includes statements like “led clinical pharmacology strategy and FIH dose selection” or “accountable for exposure–response in Phase 1/2.” Avoid pure modeling profiles; the ideal expert has decision accountability, not just analytical skill. Expectations Write “golden” FIH dose rationales and escalation strategies for representative programs. Encode the decision heuristics and trade-offs used by senior translational leaders into structured guidance and rubrics. Surface unwritten decision rules — when and why experienced teams override model-based recommendations. Inputs given: Representative drug programs or data packets (GLP tox summaries, PK/PD tables, potency & MoA context). Target prompts for translational decision-making (e.g., “Recommend FIH dose and escalation strategy given these data”). Expected outputs: Golden Decision Memos: exemplar dose justification memos that reflect the level of reasoning and format expected from top-tier translational pharmacologists. Decision Rubrics: scoring guides capturing acceptable vs. unsafe dose rationales, missed edge cases, or failure modes. Meta-Layer Commentary: short narrative explaining unspoken heuristics — how senior teams weigh risk tolerance, potency data, or tox uncertainty.
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Director Pharmacokinetics
vor 2 Wochen
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Principal Scientist, Pharmacokinetics
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Production Operator
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Production Operator
vor 1 Woche
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SAP Solution Architect FI/CO
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Studentische Aushilfe
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Research Assistant
Vor 3 Tagen
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