This role is for one of our clients
Compensation: $175-$250 per hour
We are looking for an external expert who brings true decision-maker accountability—someone who has personally driven translational and early clinical pharmacology decisions under real-world constraints, uncertainty, and governance scrutiny. This role requires deep judgment, not just modeling expertise.
Requirements
Who We’re Looking For
- Direct, hands-on ownership of FIH starting dose selection, SAD/MAD design, and Phase 2 dose recommendations across multiple programs.
- Experience presenting and defending dose/exposure rationales to governance committees, senior leadership, or regulatory bodies.
- Ability to integrate nonclinical → clinical translation across tox, PK, PD, potency, and mechanism of action.
- Strong understanding of the true decision calculus behind dose selection, including safety margins, pharmacologic confidence, and speed-to-proof considerations.
- Capable of converting expert judgment into explicit rules, heuristics, and rubrics suitable for training or evaluating AI systems.
Important: This role is not for pure modelers — we need someone who has owned the decisions, not just the analyses.
Experience Level
- 10+ years in biopharma, biotech, or specialized translational pharmacology consulting.
- Led FIH dose selection and/or SAD/MAD escalation strategies for 2–3 or more clinical assets.
- Demonstrated governance experience (e.g., IND dose justification, exposure–response strategy, Phase 1/2 rationale presentations).
- Track record containing statements such as:
- “Led clinical pharmacology strategy and FIH dose selection”
- “Accountable for exposure–response decisions in Phase 1/2”
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- Deep understanding of how real-world translational decisions are made under uncertainty and conflicting data.
Expectations
- Develop benchmark-level FIH dose rationales and escalation strategies for representative programs.
- Translate senior translational leaders’ decision heuristics into structured rubrics and guidance.
- Identify and articulate the unwritten rules that experienced teams apply when overriding model-based recommendations or when navigating ambiguous data.
Inputs Provided
- Representative drug program packets (GLP tox summaries, PK/PD tables, potency and MoA information).
- Decision prompts (e.g., “Recommend FIH starting dose and escalation plan based on these data”).
Expected Outputs
1. Golden Decision Memos
High-quality dose justification documents mirroring what top-tier translational leaders produce—clear logic, grounded assumptions, and defensible rationale.
2. Decision Rubrics
Structured scoring frameworks capturing:
- What constitutes a robust vs. unsafe dose rationale
- Key edge cases or red flags
- Typical failure modes in translational decision-making
3. Meta-Layer Commentary
Short explanations of the implicit heuristics experts use—how risk tolerance, potency, tox uncertainty, and PK/PD evidence shape final decisions beyond purely model-driven recommendations.
Engagement Model
- Contract / Part-time / Remote
- Deliverables are outcome-focused and executed flexibly.