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
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
At Crossing Hurdles, we specialise in customised recruitment and staffing solutions designed to drive success for businesses and professionals.
Funding
Current Stage
Early StageCompany data provided by crunchbase