Executive Director, DMPK
Core
Develops strategic plans and leads the Preclinical Pharmacokinetics function to ensure clinical candidates are identified, characterized, and developed for neurological, neuroendocrine, and neuropsychiatric disorders.
Role type
Executive Director, Preclinical Pharmacokinetics
Builds
Preclinical development compounds for FDA-approved treatments and pipeline candidates in mid- to late-phase clinical development
Domain
Biopharmaceuticals / Neuroscience / Pharmacokinetics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
strategic planning, functional leadership, managing Contract Research Organizations, regulatory document preparation (INDs, NDAs, MAAs), study design and conduct, data summarization, SOP development, cross-functional collaboration
Preferred skills
in silico modeling and simulation tools, problem-solving, negotiation and influence, employee development
Technologies
in silico modeling and simulation tools
Responsibilities
Provides strategic leadership to the Preclinical Pharmacokinetic function; develops and enables departmental strategies for evaluating Preclinical Pharmacokinetics; leads and manages the conduct, interpretation, and reporting of preclinical pharmacokinetic studies; designs and conducts Preclinical Pharmacokinetic and Toxicokinetic/Pharmacokinetic/Pharmacodynamic studies; oversees preparation of Preclinical Pharmacokinetic sections of regulatory documents; prepares Standard Operating Procedures (SOPs); presents results to peers, colleagues, the Management Committee, and regulatory agencies.
Seniority
Executive, strategic leadership & management
