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.

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.