PKPD Module expert Translational Clinical Pharmacology Decision-Maker

The client is seeking an external expert who brings a decision-makers mindset someone who has personally driven translational pharmacology choices under governance and uncertainty.

Who were 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 23 assets.

• Proven governance experience: IND sign-off dose justification memos exposureresponse presentations.

• CV or track record includes statements like led clinical pharmacology strategy and FIH dose selection or accountable for exposureresponse 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.