Mercor
PK/PD Module expert: Translational / Clinical Pharmacology Decision-Maker
Mercor, Boston, Massachusetts, us, 02298
The client is seeking an external expert who brings a
decision-maker’s mindset
— someone who has personally driven translational pharmacology choices under governance and uncertainty. Who we’re 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 ≥2–3 assets.
Proven governance experience: IND sign-off, dose justification memos, exposure–response presentations.
CV or track record includes statements like
“led clinical pharmacology strategy and FIH dose selection”
or
“accountable for exposure–response 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.
#J-18808-Ljbffr
decision-maker’s mindset
— someone who has personally driven translational pharmacology choices under governance and uncertainty. Who we’re 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 ≥2–3 assets.
Proven governance experience: IND sign-off, dose justification memos, exposure–response presentations.
CV or track record includes statements like
“led clinical pharmacology strategy and FIH dose selection”
or
“accountable for exposure–response 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.
#J-18808-Ljbffr