PK/PD Translational Pharmacology Expert at Mercor

Translational Pharmacology Expert | $175–250/hr | Remote Worldwide

We are seeking a senior translational pharmacology expert with proven decision-making authority in first-in-human (FIH) dose selection and clinical pharmacology strategy. This role requires someone who has personally driven critical translational decisions under regulatory and governance scrutiny.

Who We're Looking For

• Owned FIH starting dose, SAD/MAD design, and Phase 2 dose selection for multiple drug assets
• Participated in governance or review boards, defending dose and exposure rationale to senior leadership or regulators
• Demonstrated expertise in balancing nonclinical-to-clinical translation across toxicology, PK, PD, potency, and mechanism of action
• Ability to articulate the real decision calculus behind dose selection, considering safety, pharmacology, and speed-to-proof
• Capable of translating narrative judgment into explicit decision rules and rubrics for AI training and evaluation

Required Experience

• 10+ years in major biopharma or biotech (e.g., Lilly, Roche, AbbVie, Amgen, Novartis, GSK, Regeneron, Vertex, Incyte, Gilead) or specialized translational pharmacology consulting
• Personally led FIH dose and/or SAD/MAD escalation for at least 2–3 assets
• Proven governance experience including IND sign-off, dose justification memos, and exposure-response presentations
• Track record demonstrating accountability for clinical pharmacology strategy and FIH dose selection
• Decision accountability experience, not just analytical or modeling skills

Key Responsibilities

• Write exemplar FIH dose rationales and escalation strategies for representative drug programs
• Encode decision heuristics and trade-offs used by senior translational leaders into structured guidance and rubrics
• Surface unwritten decision rules explaining when and why experienced teams override model-based recommendations

Deliverables

• Golden Decision Memos: Exemplar dose justification memos reflecting top-tier translational pharmacology reasoning
• Decision Rubrics: Scoring guides capturing acceptable vs. unsafe dose rationales and potential failure modes
• Meta-Layer Commentary: Narrative explaining unspoken heuristics and how senior teams weigh risk tolerance, potency data, and toxicology uncertainty

You will work with representative drug programs, GLP tox summaries, PK/PD data, potency information, and mechanism of action context to create decision frameworks that capture expert-level translational pharmacology judgment.