Job Description

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.