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About 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. 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.

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.

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.
• Oncology drug development experience, including expertise in small-molecule development and dose optimization, is strongly preferred.

Skills

• Clinical Pharmacology
• Model-Informed Drug Development (MIDD)
• Population PK
• PK/PD modeling
• Exposure-response analysis
• Model-based meta-analysis
• Disease progression modeling
• Clinical trial simulations
• NONMEM
• R
• Phoenix NLME
• Regulatory submissions (INDs, CTAs, NDA/BLA)
• Health authority interactions
• Small molecule development
• Dose optimization

Location

• New York, NY

Work Type

• Remote

Experience Level

• Senior Director
• 15+ years

Education Level

• PhD
• PharmD
• Equivalent advanced degree

Salary/Compensations

• $285,000 - $305,000

Benefits

• Equity offering
• Annual target bonuses
• Outstanding benefits program

About the Company

• Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
• Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor.
• Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment.
• For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

Equal Opportunity

• Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.