Senior ADME and Quantitative Pharmacology Director

Responsibilities Lead DMPK and PK/PD strategy across discovery and development programs, from candidate nomination through clinical development and regulatory submission Drive clinical pharmacology strategy including dose finding, exposure–response modeling, PK/PD analysis, and risk-benefit assessment for early- and late-stage programs Oversee PK/PD study design, analysis, and interpretation, collaborating with clinical operations, biostatistics, and regulatory colleagues Provide scientific and regulatory support for DMPK, Clinical Pharmacology, and Biopharmaceutics sections of regulatory submissions, including IND, NDA, and BLA filings Act as the subject‑matter expert for clinical pharmacology and DMPK in interactions with FDA, EMA, and other global health authorities Partner with translational, discovery, and clinical teams to integrate nonclinical ADME data into clinical development plans and support compound progression from pipeline to early development Work closely with Discovery and DMPK groups to provide PK/ADME support for discovery projects, enabling informed compound selection and optimization Ensure alignment of DMPK and PK/PD activities with clinical development, drug manufacturing, and regulatory plans across the portfolio Provide strategic and technical leadership to the AQP function on scientific matters, combining full‑time and consulting resources Plan and conduct stage‑appropriate Clinical Pharmacology studies (Phase I/II/III) to support regulatory submissions Requirements PhD, PharmD, or MD in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline with 15+ years of relevant experience in biotech or pharma Demonstrated expertise in PK/PD, modeling & simulation, dose finding, and exposure-response strategies across nonclinical and clinical development Strong knowledge of Health Authority regulations and guidelines (ICH, FDA, EMA) for the development of small molecule therapies, with expert knowledge of those relating to Clinical Pharmacology/PK/PD Proven success representing Clinical Pharmacology and DMPK in regulatory interactions with FDA and ideally other regulators (e.g., FDA Pre‑IND and EMA Scientific Advice meetings), and supporting IND, NDA, or BLA filings Extensive familiarity with major CROs and the ability to manage collaborations with CROs, academia, and industry partners Leadership experience managing teams and cross‑functional collaborations, with excellent communication skills and the ability to influence at all levels from scientists to executive leadership Ability to manage multiple therapeutic programs in parallel and prioritize according to the needs of the company while delivering on key milestones Familiarity with non-oral small molecule delivery (formulation) approaches is a bonus; strong appreciation for research with a focus on product development. #J-18808-Ljbffr