Remotehey

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.