Neuroscience Clinical Research VP, Early-Phase Development

Regulatory Jobs; United States; On-site; USD 269,000 - 433,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Job summary

Lilly seeks an experienced Clinical Research Physician to lead early-phase clinical development, with expertise in clinical pharmacology and neuroscience drug development. The role involves progressing assets to first‑in‑human studies, managing regulatory interactions, and guiding biomarker strategies within a global trials program.

The candidate will ensure compliance with GCPs, FDA/ICH guidance, and internal Lilly standards while collaborating with discovery scientists and regulatory teams to

Qualifications

• MD or DO required; board eligibility/certification preferred.
• At least 10 years in the pharmaceutical industry or similar experience relevant to early clinical development.
• Experience in neuroscience, neurodegeneration, and/or pain research is a plus.

Responsibilities

• Design and oversee early phase clinical pharmacology studies including SAD/MAD, biomarker plans, and mechanistic studies.
• Lead regulatory interactions and ensure compliance with FDA/ICH guidelines and GCPs.
• Collaborate with cross-functional teams to plan pre-clinical and translational activities supporting first‑in‑human and submission studies.

Skills

Clinical pharmacology

Early clinical development

Neuroscience drug development

Regulatory knowledge

Communication skills

Education

MD/DO

Board eligibility/certification

Job description

Lilly seeks an experienced Clinical Research Physician to lead early-phase clinical development, with expertise in clinical pharmacology and neuroscience drug development. The role involves progressing assets to first‑in‑human studies, managing regulatory interactions, and guiding biomarker strategies within a global trials program.

The candidate will ensure compliance with GCPs, FDA/ICH guidance, and internal Lilly standards while collaborating with discovery scientists and regulatory teams to