DMPK Project Lead - Senior Director, CNS

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 177,000 - 339,000; Full time

Benefits offered by this job

Company bonus program

Comprehensive benefits package

Job summary

Lilly in Indianapolis, IN is seeking a Senior Director, DMPK Project Lead to drive end-to-end DMPK activities across discovery and development teams. The role focuses on PK/PK modeling, ADME, regulatory submissions, and cross-functional leadership to advance CNS drug candidates.

The position requires 10+ years in biotech/pharma, a Ph.D., and proven DMPK leadership with NDA experience. Occasional travel and a strong sense of urgency are expected.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacology or related field.
• Minimum of 10 years of industry experience in biotech/pharma.
• Expert in DMPK sciences with knowledge of discovery and development.
• Strong analytical and problem-solving skills.
• Experience in DMPK project leadership and CNS drug candidates.
• Experience with regulatory submissions including NDAs for small molecules.
• Proficient in GLP-compliant studies and PK modeling software.

Responsibilities

• Lead the filing of NDAs for DMPK.
• Deliver high-quality DMPK input to projects within timelines.
• Support compound profiling and project strategy using DMPK knowledge.
• Calculate PK and toxicokinetic parameters and report to governance bodies.
• Coordinate with DMPK, clinical pharmacologists and toxicologists on activities.
• Prepare presentations for internal governance bodies.

Skills

DMPK leadership

NDA submissions

PK/PK modeling

ADME knowledge

CNS drug development

cross-functional leadership

GLP studies

Phoenix WinNonlin

data interpretation

communication

Education

Ph.D. in Pharmaceutical Sciences or related field

Tools

WinNonlin

in silico PK tools

Job description

Lilly in Indianapolis, IN is seeking a Senior Director, DMPK Project Lead to drive end-to-end DMPK activities across discovery and development teams. The role focuses on PK/PK modeling, ADME, regulatory submissions, and cross-functional leadership to advance CNS drug candidates.

The position requires 10+ years in biotech/pharma, a Ph.D., and proven DMPK leadership with NDA experience. Occasional travel and a strong sense of urgency are expected.