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PK/PD Module Expert – Translational, Clinical Pharmacology Decision-Maker

TranslatorTranslatorPart TimeRemoteLeadTeam 11-50Since 2021H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

113 days ago

Salary

$175 - $250 / hour

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

• 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. • Deliverables are outcome-focused and executed flexibly.

Job Requirements

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.
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”
Deep understanding of how real-world translational decisions are made under uncertainty and conflicting data.