About this opportunity
CORE Biomedicine, Inc. lists this Senior Director/VP, Clinical Pharmacology opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Director/VP, Clinical Pharmacology
Company Overview:
CORE Biomedicine Inc. is a pioneering biotech startup dedicated to advancing novel therapies in oncology. We specialize in the development of small molecule drugs targeting novel pathways for the treatment of various cancers.
Position Overview:
We are seeking a dynamic and experienced individual, with strong multitasking skills to support our ongoing pre-clinical IND-enabling studies research. The person will lead Clinical Pharmacology research for the various CORE oncology programs.
Key Responsibilities:
Lead clinical pharmacology and translational strategy from IND through early clinical development (Phase 1–2)
Design and interpret clinical PK, PK/PD, and exposure–response analyses to support dose selection and development decisions
Develop and apply pharmacometric models (population PK, PK/PD, MIDD approaches) to guide clinical study design
Partner with DMPK, toxicology, biology, and clinical teams to ensure preclinical-to-clinical translation
Support first-in-human (FIH) dose selection and escalation strategies
Author and review clinical pharmacology sections of INDs, IBs, protocols, CSRs, and regulatory responses
Collaborate with clinical operations and external vendors to ensure high-quality PK sampling, bioanalysis, and data integrity
Interact with regulatory agencies on clinical pharmacology and MIDD topics, as needed
Communicate complex quantitative analyses clearly to multidisciplinary teams and senior leadership
Qualifications:
PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacometrics, or related discipline
2–6+ years of relevant industry experience in clinical pharmacology or pharmacometrics (title commensurate with experience)
Strong expertise in clinical PK, PK/PD, population modeling, and exposure–response analyses
Hands-on experience with modeling and simulation tools (e.g., NONMEM, Monolix, Phoenix NLME, R)
Familiarity with IND-enabling and early clinical development for small-molecule therapeutics
Working knowledge of regulatory expectations for clinical pharmacology and MIDD
Experience collaborating with CROs and managing outsourced modeling or bioanalytical activities
Excellent written and verbal communication skills
Ability to thrive in a hands-on, fast-paced startup environment with evolving priorities
Competitive compensation
Paid time off (vacation, holidays, and sick leave)
Flexible work arrangements (hybrid or remote options where applicable)
401k, Bonus, Equity, Healthcare (Medical, Dental, Vision)
Opportunity to work at the forefront of cancer research in a mission-driven startup environment
#J-18808-Ljbffr
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.