PKPD Module expert Translational Clinical Pharmacology Decision-Maker

Berlin - Germany

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

The client is seeking an external expert who brings a decision-makers mindset someone who has personally driven translational pharmacology choices under governance and uncertainty.

Who were looking for

Has owned FIH starting dose SAD/MAD design and Phase 2 dose selection for multiple assets.
Participated in governance or review boards defending dose/exposure rationale in front of senior leadership or regulators.
Demonstrates ability to balance nonclinical clinical translation: tox PK PD potency and MoA.
Can articulate the real decision calculus behind dose selection (safety pharmacology speed-to-proof).
Capable of turning narrative judgment into explicit decision rules and rubrics for AI training and evaluation.

Experience level

10 years in major biopharma or biotech (e.g. Lilly Roche AbbVie Amgen Novartis GSK Regeneron Vertex Incyte Gilead) or in specialized translational pharmacology consulting.
Has personally led FIH dose and/or SAD/MAD escalation for 23 assets.
Proven governance experience: IND sign-off dose justification memos exposureresponse presentations.
CV or track record includes statements like led clinical pharmacology strategy and FIH dose selection or accountable for exposureresponse in Phase 1/2.
Avoid pure modeling profiles; the ideal expert has decision accountability not just analytical skill.

Expectations

Write golden FIH dose rationales and escalation strategies for representative programs.
Encode the decision heuristics and trade-offs used by senior translational leaders into structured guidance and rubrics.
Surface unwritten decision rules when and why experienced teams override model-based recommendations.

Inputs given:

Representative drug programs or data packets (GLP tox summaries PK/PD tables potency & MoA context).
Target prompts for translational decision-making (e.g. Recommend FIH dose and escalation strategy given these data).

Expected outputs:

Golden Decision Memos: exemplar dose justification memos that reflect the level of reasoning and format expected from top-tier translational pharmacologists.
Decision Rubrics: scoring guides capturing acceptable vs. unsafe dose rationales missed edge cases or failure modes.
Meta-Layer Commentary: short narrative explaining unspoken heuristics how senior teams weigh risk tolerance potency data or tox uncertainty.

The client is seeking an external expert who brings a decision-makers mindset someone who has personally driven translational pharmacology choices under governance and uncertainty. Who were looking for Has owned FIH starting dose SAD/MAD design and Phase 2 dose selection for multiple assets. Pa...