Senior DMPK Project Leader — Remote CNS Focus

Lifelancer Ltd; United States; Remote; USD 177,000 - 339,000; Full time

Job summary

The Senior Director, DMPK Project Leader at Lilly leads DMPK activities across a cross-functional program team, overseeing nonclinical PK, in vitro ADME, biotransformation, bioanalytical and toxicokinetic analyses to advance CNS drug candidates. The role emphasizes NDA readiness, PK/TK interpretation, and cross-functional influence on portfolio progression.

The ideal candidate has a PhD with 10+ years in biotech/pharma, strong DMPK expertise, and demonstrated leadership in CNS development and

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacology or a related field.
• Minimum of 10 years of industry experience in a biotech or pharmaceutical setting.
• Expert in DMPK sciences with knowledge of drug discovery and development processes.
• Strong analytical and problem-solving skills.
• Experience in DMPK project leadership.
• Previous work in the discovery and/or development of CNS drug candidates.
• Experience with regulatory submissions including NDAs for small molecules.
• Knowledge, experience, and proficiency in supporting GLP-compliant studies.
• Good knowledge of all DMPK assays including the use of in silico tools for PK prediction.
• Proficiency with Phoenix WinNonlin and other software for NCA and PK modeling in small molecule drug discovery and development.
• Demonstrated ability to work cross-functionally and communicate scientific findings clearly and effectively.
• Collaborative mindset and operates with a sense of urgency.
• Strong, proactive communication skills.

Responsibilities

• Lead the filing of NDAs for DMPK.
• Deliver high-quality DMPK input and data to projects within established timelines.
• Utilize knowledge of DMPK to support/influence compound profiling, project progression and project strategy.
• Proactively calculate PK and toxicokinetic parameters, estimate safety margins and report results and interpretations to project teams and internal governance bodies.
• Lead, coordinate, and engage with DMPK colleagues, clinical pharmacologists, and toxicologists in project related activities.
• Prepare clear presentations related to the above for internal governance bodies.

Skills

DMPK expertise

PK modeling

CNS drug development

Regulatory submissions

GLP studies experience

Cross-functional collaboration

Communication skills

Phoenix WinNonlin

Education

Ph.D. in Pharmaceutical Sciences or Pharmacology

Job description

The Senior Director, DMPK Project Leader at Lilly leads DMPK activities across a cross-functional program team, overseeing nonclinical PK, in vitro ADME, biotransformation, bioanalytical and toxicokinetic analyses to advance CNS drug candidates. The role emphasizes NDA readiness, PK/TK interpretation, and cross-functional influence on portfolio progression.

The ideal candidate has a PhD with 10+ years in biotech/pharma, strong DMPK expertise, and demonstrated leadership in CNS development and