Director, Cardiometabolic Clinical Research & PV

Regulatory Jobs; Indianapolis (IN); In loco; USD 201.000 - 361.000; Tempo pieno

Vantaggi offerti da questo lavoro

Company bonus

401(k) plan

Descrizione del lavoro

Lilly is seeking a Clinical Research Physician (CRP) for GPS Medical to lead safety oversight across assets in development and post-launch phases. You will interact with Regulatory, Clinical Development Teams, and external stakeholders while ensuring PV best practices and regulatory compliance.

Responsibilities include medical review of safety data, risk assessment, and ensuring timely, scientifically sound medical decisions. A strong background in pharmacovigilance and drug safety is required.

Competenze

• MD or DO degree with board eligibility or certification in the relevant specialty.
• Minimum 3+ years of pharmaceutical industry or clinical care experience.
• Fluent English with strong written and verbal communication skills.
• Knowledge of drug development, pharmacovigilance guidelines and regulatory expectations.

Mansioni

• Provide medical leadership and PV oversight for assigned products throughout lifecycle.
• Review safety data, perform causality assessments and request follow-up as needed.
• Oversee safety surveillance activities, risk management decisions and regulatory inquiries.
• Collaborate with internal and external stakeholders to sustain safety and compliance.
• Represent GPS Medical in inspections, audits, and cross-functional safety initiatives.

Conoscenze

Pharmacovigilance

Clinical research

PV oversight

Formazione

MD/DO

Descrizione del lavoro

Lilly is seeking a Clinical Research Physician (CRP) for GPS Medical to lead safety oversight across assets in development and post-launch phases. You will interact with Regulatory, Clinical Development Teams, and external stakeholders while ensuring PV best practices and regulatory compliance.

Responsibilities include medical review of safety data, risk assessment, and ensuring timely, scientifically sound medical decisions. A strong background in pharmacovigilance and drug safety is required.