Environmental Risk Assessment Leader, Global Portfolio

BioSpace; Indianapolis (IN); On-site; USD 149,000 - 257,000; Full time

Benefits offered by this job

401(k) plan

Pension program

Medical, dental, vision coverage

Well-being benefits

Job summary

Lilly in Indianapolis seeks an ERA Group Leader to oversee environmental studies and risk assessments for global regulatory submissions. You will lead scientific strategy, guide CRO partnerships, ensure GLP compliance, and deliver timely results for PiE initiatives.

You will mentor environmental scientists, collaborate across manufacturing, regulatory, and GHSE teams, and shape regulatory strategy while advising on discharge limits to protect people and ecosystems.

Qualifications

• PhD in environmental or natural sciences, or related field.
• 15 years experience in chemical environmental risk assessment in pharmaceutical or pesticide industry and/or as consultant to such industries.
• Research experience in environmental toxicology and/or environmental fate.
• Experience with OECD environmental studies and GLPs.
• Confirmed skills in scientific communication via published papers and presentations.

Responsibilities

• Lead the ERA Group by setting scientific direction, developing environmental scientists, and building environmental risk assessment capability across the portfolio.
• Own portfolio ERA testing, prioritization, study governance, and submission-ready delivery for global regulatory registrations.
• Direct execution of environmental studies that meet regulatory expectations through fit-for-purpose CRO partnerships that ensure GLP compliance, data quality, and reliable report delivery.
• Advance Lilly's ERA science by identifying and fostering innovative solutions and cross-functional collaboration.
• Communicate ERA strategy, risks, decisions, and regulatory implications to Lilly leadership, project teams, and regulatory functions.
• Advise manufacturing on pharmaceutical discharge limits and implementation strategies that protect people, ecosystems, and business continuity.
• Lead PiE governance by assessing internal and external developments, framing business implications, and driving mitigation strategies through cross-functional partnership with GHSE, Governmental Affairs, R&D.
• Represent Lilly externally to benchmark guidelines, influence regulatory expectations, shape industry positions, and guide external research engagement.

Skills

Scientific communication

Cross-functional collaboration

Education

PhD in environmental or natural sciences

Job description

Lilly in Indianapolis seeks an ERA Group Leader to oversee environmental studies and risk assessments for global regulatory submissions. You will lead scientific strategy, guide CRO partnerships, ensure GLP compliance, and deliver timely results for PiE initiatives.

You will mentor environmental scientists, collaborate across manufacturing, regulatory, and GHSE teams, and shape regulatory strategy while advising on discharge limits to protect people and ecosystems.