Director - Clinical Research Physician, GPS Medical - Cardiometabolic Health

Eli Lilly and Company•Us, IN

About The Position

The Clinical Research Physician (CRP) in GPS Medical leads and oversees safety activities for one or more assets throughout their product life cycles. The role coordinates technical functions within Global Patient Safety (GPS), partners with integrated development or product teams to meet safety commitments, and represents Lilly GPS Medical to internal and external stakeholders. Responsibilities for specific products or projects are agreed individually. The CRP provides proactive pharmacovigilance and medical oversight of safety surveillance, signal decisions, risk management, regulatory safety queries, and safety information. The role contributes to early-phase case reviews, interprets complex safety data, supports product assessments and manufacturing-related safety investigations, and represents GPS Medical in audits, inspections, and cross-functional forums. The CRP may also support acquisitions and integrations, safety advisory committees, and aggregate product complaint and adverse-event surveillance. The position includes people leadership, talent development, and training, coaching, and mentoring in pharmacovigilance. It also supports the European Union Qualified Person (QPPV) in fulfilling legal responsibilities and maintains compliance with Lilly policies, curricula, and the Corporate Integrity Agreement.

Requirements

Medical Doctor (MD) or Doctor of Osteopathy (DO).
Board eligible or certified in an appropriate specialty or subspecialty, or have completed comparable post-medical-school clinical training relevant to the country of hiring.
US-trained physicians must be board eligible or certified; exceptions for foreign medical graduates in US-based roles may be made at the discretion of the Chief Medical Officer.
For non-US-trained physicians, medical education and training must meet minimum requirements substantially equivalent to those of medical schools accredited by the Liaison Committee on Medical Education (LCME).
At least 3 years of experience in the pharmaceutical industry or a clinical care setting.
Board certification in Internal Medicine or Endocrinology.
Fluent English and highly effective written and verbal communication skills.
Strong clinical and diagnostic skills.
Excellent interpersonal, organizational, and negotiation skills.
Ability to work on multiple projects in a fast-paced, matrixed environment.
Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines.
Ability to influence others across functions and within the function.
Excellent teamwork skills.
Willingness to travel domestically and internationally as appropriate to support the team.
Knowledge of global pharmacovigilance guidelines, guidance, and regulations, including EMA and FDA requirements relevant to the role.
Strategic thinking and demonstrated success implementing projects and/or innovating.
Receptive, engaging, and impactful contributor.

Nice To Haves

Prior clinical-trial experience in academia and/or industry.
Clinical development or pharmacovigilance experience.
Knowledge of the drug-development process.

Responsibilities

Provide GPS Medical leadership and proactive pharmacovigilance for assigned products.
In early-phase development, conduct or contribute to medical review of individual case safety reports for completeness and accuracy, including company causality assessments and follow-up requests as needed.
Oversee safety surveillance, safety signal decisions, risk-management actions, and related communications or escalations.
Monitor safety activities for their impact on Core Safety Information and Core Risk Minimization activities.
Build collaborative relationships that support effective drug development and high-quality medical evaluation of safety data.
Oversee responses and actions related to regulatory queries on safety topics.
Lead GPS Medical activities during acquisitions and integrations of companies or assets, supporting continuity of safety surveillance.
Represent GPS Medical with internal and external stakeholders, including product and business leaders, Regulatory, affiliate medical leadership, clinical research physicians, COE, Discovery and Clinical Research, and external opinion leaders.
Review and comment on external regulatory policies and trends affecting Global Patient Safety.
Represent GPS Medical in inspection and audit activities for assigned programs.
Contribute to safety advisory hub committees and cross-functional consultative bodies as needed.
Provide medical input to safety surveillance teams evaluating aggregate product complaint and adverse-event data for potential manufacturing-quality safety signals.
Make timely medical assessments and decisions for Product Safety Assessments, Health Hazard Evaluations, and other risk-assessment documentation.
Assess safety issues related to device design, development, risk management, periodic reporting, CMC activities, anticounterfeiting, product shortages, quality triage, and regulatory reporting.
Clinically evaluate adverse events for possible manufacturing-related root causes and implement PSA/HHE processes with manufacturing or marketing partners.
Prepare medical complaints arising from AE/PC and Device Surveillance signals, review manufacturing investigation results, and escalate identified safety issues as needed.
Proactively monitor for unanticipated safety impacts related to deviations addressed by HHEs.
Foster an inclusive, collaborative Team Lilly working environment.
Recruit, mentor, develop, and retain clinical, scientific, and drug-development talent, and ensure staff follow company policies and procedures.
Understand and support the QPPV role, enabling the Qualified Person to fulfill legal responsibilities.
Train, coach, and mentor colleagues on effective pharmacovigilance strategies and share knowledge to advance GPS and enterprise goals.
Maintain compliance with the Lilly Red Book, corporate policies, applicable curricula, and the Lilly Corporate Integrity Agreement.

Benefits

Company bonus, depending in part on company and individual performance.
Eligibility to participate in a company-sponsored 401(k).
Pension.
Vacation benefits.
Eligibility for medical, dental, vision, and prescription drug benefits.
Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
Life insurance and death benefits.
Time-off and leave-of-absence benefits.
Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
Employee resource groups open to all employees.