Senior Director, Clinical Pharmacology

Syndax Pharmaceuticals•New York, NY

2d•$285,000 - $305,000•Remote

About The Position

Syndax Pharmaceuticals is seeking a strategic and experienced Clinical Pharmacology leader to drive clinical pharmacology and model-informed drug development (MIDD) strategies across our development portfolio. 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.

Requirements

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.
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 developing scientists, leading cross-functional initiatives, and effectively managing external consultants, CROs, and strategic partners to deliver high-quality outcomes and business impact.
Strong scientific judgment, critical thinking, and problem-solving skills, with a proactive, results-oriented mindset and the ability to balance strategic vision with operational execution.

Nice To Haves

Familiarity with modeling and simulation software such as NONMEM, R, and Phoenix NLME is highly desirable.
Oncology drug development experience, including expertise in small-molecule development and dose optimization, is strongly preferred.

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.