PK/PD Module expert: Translational

vor 2 Wochen

Zürich, Zürich, Schweiz MERCOR Vollzeit CHF 80'000 - CHF 160'000 pro Jahr

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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