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.
#J-18808-Ljbffr