Director of Clinical Pharmacology & Early-Phase Development

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

Benefits offered by this job

401(k) and pension

Medical/dental/vision benefits

Well-being programs

Job summary

Lilly in Indianapolis, Indiana seeks a Clinical Research Scientist (CRS) to advance early clinical assets to first-in-human studies and oversee mechanistic pharmacology studies. The CRS collaborates with PK/PD, safety, and statistics teams to ensure rigorous data generation and compliant trial conduct.

The role emphasizes regulatory submissions, global trial execution, and mentoring of junior staff within a strong scientific, patient‑focused team at Lilly.

Qualifications

• Advanced degree in pharmacology/related biomedical science required.
• Experience with early-phase clinical pharmacology studies preferred.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Design and oversee early-phase clinical pharmacology studies.
• Collaborate with PK/PD, safety, statistics and translational teams.
• Develop biomarker plans and support regulatory submissions.
• Prepare protocol development and study initiation activities.
• Ensure compliance with GCPs and local regulations across sites.

Skills

Clinical pharmacology

Clinical trial design

Regulatory knowledge

English fluency

Education

Advanced health/medical/scientific graduate degree (Pharmacology, Physiology, Microbiology) or PharmD/PhD/MSN

Job description

Lilly in Indianapolis, Indiana seeks a Clinical Research Scientist (CRS) to advance early clinical assets to first-in-human studies and oversee mechanistic pharmacology studies. The CRS collaborates with PK/PD, safety, and statistics teams to ensure rigorous data generation and compliant trial conduct.

The role emphasizes regulatory submissions, global trial execution, and mentoring of junior staff within a strong scientific, patient‑focused team at Lilly.