Clinical PK/PD Strategy Lead | Remote jobs in United States
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Crossing Hurdles ยท 3 days ago

Clinical PK/PD Strategy Lead | Remote

Crossing Hurdles is seeking a Clinical PK/PD Strategy Lead to develop dose rationales and escalation strategies for drug programs. The role involves translating pharmacology decision-making into structured guidance and collaborating with AI researchers on clinical pharmacology decisions.

Staffing & Recruiting

Responsibilities

Develop gold-standard First-in-Human (FIH) dose rationales and escalation strategies for representative drug programs
Translate real-world translational pharmacology decision-making into structured guidance for AI training and evaluation
Encode decision heuristics, trade-offs, and governance-level judgment into clear rubrics and decision rules
Evaluate AI-generated PK/PD and dose-selection outputs for scientific rigor, safety, and decision quality
Surface and document unwritten decision rules used by senior translational leaders when overriding model-based recommendations
Collaborate asynchronously with AI researchers to refine model reasoning around clinical pharmacology decisions

Qualification

Translational pharmacologyFIH dose selectionGovernance board participationNonclinical-to-clinical translationWritten communication skills

Required

Strong experience in translational or clinical pharmacology within major biopharma, biotech, or specialized consulting environments
Direct ownership of FIH starting dose selection, SAD/MAD design, and Phase 2 dose selection for multiple assets
Proven experience participating in governance or review boards, including IND sign-off and dose-justification defense
Deep understanding of nonclinical-to-clinical translation, including tox, PK, PD, potency, and mechanism of action
Ability to articulate real-world decision calculus balancing safety, pharmacology, and speed-to-proof
Strong written communication skills with the ability to convert expert judgment into explicit rules and rubrics
Comfortable working independently in a remote, project-based environment

Company

Crossing Hurdles

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At Crossing Hurdles, we specialise in customised recruitment and staffing solutions designed to drive success for businesses and professionals.

Funding

Current Stage
Early Stage
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