Senior Director Clinical Pharmacology & MIDD Strategy

Syndax Pharmaceuticals; New York (NY); On-site; USD 285,000 - 305,000; Full time

Job summary

Syndax Pharmaceuticals is seeking a Senior Director, Clinical Pharmacology to lead clinical pharmacology strategy and model-informed drug development across the development portfolio. Reporting to the Head of Clinical Pharmacology, the role provides scientific leadership for small molecule programs and oversees PK/PD, MIDD, and regulatory interactions.

Based at our New York office, you will mentor scientists, drive regulatory submissions (INDs, CTAs, NDA/BLA), and partner with cross-functional

Qualifications

• PhD, PharmD, or equivalent advanced degree in Clinical Pharmacology or related field.
• 15+ years of experience in pharma/biotech with scientific leadership in drug development.
• Strong quantitative pharmacology expertise in population PK, PK/PD, and exposure–response.
• Experience with regulatory submissions (INDs, CTAs, NDA/BLA) and health authority interactions.
• Proficiency with NONMEM, R, and Phoenix NLME.
• Excellent written, verbal, and presentation skills; strong collaboration across functions.
• Oncology small-molecule dose optimization experience preferred.

Responsibilities

• Define and drive the overall clinical pharmacology strategy across development plans.
• Plan, design, oversee, and interpret clinical pharmacology studies (FIH, bioequivalence, food effect, QT).
• Apply MIDD approaches to inform development decisions.
• Lead population PK, PK/PD, exposure–response analyses and model-based meta-analyses.
• Contribute to global regulatory submissions (INDs, CTAs, NDA/BLA) and health authority responses.
• Mentor and develop clinical pharmacology scientists and manage external collaborators.

Skills

Population PK

PK/PD modeling

Exposure–response analyses

Model-based meta-analysis

Clinical trial simulations

Regulatory submissions

Regulatory interactions

Leadership & mentoring

Scientific communication

Dose optimization

Education

PhD, PharmD, or equivalent advanced degree

Tools

NONMEM

R

Phoenix NLME

Job description

Syndax Pharmaceuticals is seeking a Senior Director, Clinical Pharmacology to lead clinical pharmacology strategy and model-informed drug development across the development portfolio. Reporting to the Head of Clinical Pharmacology, the role provides scientific leadership for small molecule programs and oversees PK/PD, MIDD, and regulatory interactions.

Based at our New York office, you will mentor scientists, drive regulatory submissions (INDs, CTAs, NDA/BLA), and partner with cross-functional