PK​/PD Module expert : Translational​/Clinical Pharmacology Decision-Maker

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.

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.

~10+ years in major biopharma or biotech (e.g., Lilly, Roche, Abb Vie, 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.

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.

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” ).

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.