Senior Director,Clinical Pharmacology Job New York New York USA,Healthcare

Syndax Pharmaceuticals is looking for a Senior Director, Clinical Pharmacology

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

Syndax is seeking a strategic and experienced Clinical Pharmacology leader to drive clinical pharmacology and model-informed drug development (MIDD) strategies across our development portfolio. Reporting to the Head of Clinical Pharmacology, this individual will provide scientific and strategic leadership for small molecule development programs, leading clinical pharmacology studies and applying quantitative approaches to inform dose optimization and key development decisions from early development through global regulatory submissions.

This role offers a unique opportunity to influence development strategy, advance innovative therapies, and help shape the future growth of the Clinical Pharmacology function at Syndax.

Key Responsibilities:

Define and drive the overall clinical pharmacology strategy, ensuring alignment with the target product profile, clinical development plan, and broader program objectives.
Integrate clinical pharmacology principles and quantitative decision-making into development strategy, study design, and key program decisions.
Plan, design, oversee, and interpret clinical pharmacology studies, including first-in-human, relative bioavailability/bioequivalence, food-effect, QT, drug-drug interaction, and organ impairment studies.
Apply innovative model-informed drug development (MIDD) approaches and quantitative methodologies to inform critical development decisions.
Oversee population PK, PK/PD, exposure-response analysis, model-based meta-analysis, disease progression modeling, and clinical trial simulations.
Lead clinical pharmacology contributions to global regulatory submissions including INDs, CTAs, and NDA/BLA submissions.
Serve as the clinical pharmacology subject matter expert in health authority interactions and lead responses to regulatory clinical pharmacology questions.
Mentor, develop, and provide scientific leadership to clinical pharmacology scientists, fostering technical excellence and professional growth.

Desired Experience/Education and Personal Attributes:

PhD, PharmD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or a related scientific discipline.
15+ years of relevant experience in the pharmaceutical or biotechnology industry, including demonstrated scientific leadership in clinical drug development.
Strong quantitative pharmacology expertise, including experience in population PK and PK/PD modeling, exposure-response analyses, model-based meta-analyses, disease progression modeling, and clinical trial simulations. Familiarity with modeling and simulation software such as NONMEM, R, and Phoenix NLME is highly desirable.
Deep understanding of clinical drug development and regulatory requirements, with extensive knowledge of FDA, EMA, ICH, and GCP guidelines.
Demonstrated experience supporting global regulatory submissions and health authority interactions, including preparation of clinical pharmacology components for INDs, CTAs, NDA/BLA submissions, and regulatory briefing packages.
Excellent written, verbal, and presentation skills, with the ability to communicate complex scientific concepts effectively to diverse audiences.
Proven ability to operate effectively in a highly collaborative, matrixed environment and influence key strategic, scientific, and development decisions across functions.
Demonstrated leadership capabilities, including mentoring and…