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

Job not on LinkedIn

November 25

Apply Now

Receive Emails with Similar Jobs

Weekday (YC W21)

WebsiteLinkedInAll Job Openings

Human Resources • SaaS • Recruitment

Weekday is a modern recruitment platform that combines AI technologies with a vast database of potential candidates, aiming to streamline the hiring process for companies in India. They offer various services, including a proactive outreach approach that helps employers connect with top talent, as well as tools for candidates to easily apply for jobs. Weekday's emphasis on candidate engagement through multiple channels, including email, WhatsApp, and phone calls, sets it apart in the competitive landscape of recruitment agencies.

11 - 50 employees

Founded 2021

☁️ SaaS

🎯 Recruiter

📋 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.

🎯 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.