PK/PD Module expert: Translational / Clinical Pharmacology Decision-MakerMercor • Henderson, Nevada, US
No longer accepting applications
PK / PD Module expert : Translational / Clinical Pharmacology Decision-Maker
Mercor • Henderson, Nevada, US
1 day ago
Job type
- Full-time
- Remote
Job descriptionWho 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.
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.
###
Create a job alert for this search
Clinical Pharmacology • Henderson, Nevada, US
Related jobs
Senior Medical Editor - Regulatory - Home Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinica...Show more
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...Show more
Senior Clinical Project Manager.Are you an experienced full service Project Manager in the field of clinical trials who's engaged in addressing the challenges facing the research and development of...Show more
LocumJobsNetwork is working with CompHealth to find a qualified Hematology and Oncology MD in Las Vegas, Nevada, 89102!.Some locum assignments can be as short as a day, others, years.Some are far f...Show more
Sr Regulatory Associate PM (NA or LATAM Based Only).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique cli...Show more
Advisor, Clinical Standards - Shared Clinical Services.Director, Nursing Practice and Improvement.Director of Nursing Practice and Improvement, this position.
The incumbentwill work closely with the...Show more LocumJobsNetwork is working with Barton Associates to find a qualified Pediatrics MD in Nevada!.We are seeking a board-certified Pediatric Emergency Medicine physician for a locum tenens assignment...Show more Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...Show more 
We are seeking an experienced Clinical Systems Domain Architect - Pharmacy & Lab to join our Clinical Systems Domain Architecture team.
This highly visible full-time remote role will support the adv...Show more Regulatory Manager / Senior Regulatory Manager (Clinical Trials).Precision for Medicine is not your typical CRO.At Precision for Medicine we have brought together new technologies, expertise and op...Show more 
LocumJobsOnline is working with Barton Associates to find a qualified Pediatrics MD in Nevada!.We are seeking a board-certified Pediatric Emergency Medicine physician for a locum tenens assignment ...Show more LocumJobsOnline is working with Adelphi Locums to find a qualified Pediatrics MD in Henderson, Nevada, 89052!.Specialty : Pediatric Emergency Medicine.
Facility Location : Henderson, NV.Service Settin...Show more LocumJobsNetwork is working with Adelphi Locums to find a qualified Pediatrics MD in Henderson, Nevada, 89052!.Specialty : Pediatric Emergency Medicine.
Facility Location : Henderson, NV.Service Setti...Show more Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...Show more 
Lantheus (NASDAQ : LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcome...Show more Principal Medical Writer - Submission Docs (2.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical,...Show more 
The Tissue Donation Specialist (TDS) supports the mission, goals, and strategic plan of Nevada Donor Network Inc.NDN) by providing clinical support to facilitate safe, efficient procurement of tiss...Show more Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to acceler...Show more
Senior Medical Editor - Regulatory - Home Based
Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
Full-time
Last updated: 8 days ago • Promoted
Assoc. Dir., Med. Science Liaisons, MPN / GVHD, Southwest
Incyte • Las Vegas, NV, United States
Full-time
Last updated: 30+ days ago • Promoted
Senior Clinical Project Manager
Precision for Medicine • Las Vegas, NV, US
Full-time
Last updated: 28 days ago • Promoted
Locum Physician (MD / DO) - Hematology and Oncology in Las Vegas, NV
LocumJobsNetwork • Henderson, US
Full-time +1
Last updated: 30+ days ago • Promoted
Sr Regulatory Associate PM (NA or LATAM Based Only)
Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
Full-time
Last updated: 1 day ago • Promoted
Advisor, Clinical Standards
ArchWell Health • Las Vegas, NV, United States
Full-time
Last updated: 3 days ago • Promoted
Locum Physician (MD / DO) - Pediatrics - General / Other in Nevada
LocumJobsNetwork • Las Vegas, US
Full-time +1
Last updated: 11 days ago • Promoted
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor
Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
Full-time
Last updated: 30+ days ago • Promoted
Clinical Systems Domain Architect - Lab and Pharmacy- Remote
Sentara • Las Vegas, NV, United States
Remote
Full-time
Last updated: 12 days ago • Promoted
Regulatory Manager / Senior Regulatory Manager (Clinical Trials)
Precision for Medicine • Las Vegas, NV, US
Full-time
Last updated: 13 days ago • Promoted
Locum Physician (MD / DO) - Pediatrics - General / Other in Nevada
LocumJobsOnline • Las Vegas, US
Full-time +1
Last updated: 11 days ago • Promoted
Locum Physician (MD / DO) - Pediatrics - General / Other in Henderson, NV
LocumJobsOnline • Henderson, US
Full-time
Last updated: 30+ days ago • Promoted
Locum Physician (MD / DO) - Pediatrics - General / Other in Henderson, NV
LocumJobsNetwork • Henderson, NV, US
Full-time
Last updated: 30+ days ago • Promoted
Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based
Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
Remote
Full-time
Last updated: 16 days ago • Promoted
Senior Medical Science Liaison - Pacific Northwest (WA, OR, NV, UT, ID)
Lantheus • Henderson, NV, United States
Full-time
Last updated: 21 days ago • Promoted
Principal Medical Writer - Submission Docs (2.5 / 2.7.2 / 2.7.3 / 2.7.4) - Oncology - Remote Based
Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
Remote
Full-time
Last updated: 10 days ago • Promoted
Tissue Donation Specialist (Las Vegas)
Nevada Donor Network • Las Vegas, NV, US
Part-time
Last updated: 1 hour ago • Promoted • New!
Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based
Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
Remote
Full-time
Last updated: 16 days ago • Promoted