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

Send an email to bharathkumar.sampath@halogion.com with the Subject “PK/PD Module expert: Translational / Clinical Pharmacology Decision-Maker” showing your interest in the role to get priority consideration.

At Halogion, we are an Independent member of Mercor referral partner program. We refer candidates to our partner that collaborates with world’s leading AI research labs to build and train cutting-edge AI models

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.

We consider all qualified applicants without regard to legally protected characteristics and provide reasonable accommodations upon request.