Director - Clinical Research Physician, GPS Medical - Cardiovascular

Eli Lilly and Company • Us, IN

3d

About The Position

The Clinical Research Physician (CRP) in GPS Medical leads and supports the development, management, execution, and oversight of safety programs for assigned assets throughout their product life cycles. The CRP coordinates technical functions within Global Patient Safety (GPS), partners with integrated development or product teams to deliver safety commitments, and represents Lilly GPS Medical to internal and external stakeholders under company guidelines and policies. Specific responsibilities are agreed upon for each product or project.

The role provides medical leadership for proactive pharmacovigilance, safety surveillance, signal decisions, risk management, regulatory safety queries, and product safety assessments. It also supports safety oversight relating to devices, manufacturing, quality, and regulatory matters, including assessment of adverse events, product complaints, health hazards, manufacturing investigations, and potential safety impacts of deviations. The CRP may represent GPS Medical in audits and inspections and participate in advisory and cross-functional safety committees.

The position includes people leadership and talent development: fostering an inclusive, collaborative environment; recruiting, mentoring, developing, and retaining clinical and scientific staff; and ensuring compliance with company policies. The CRP also supports the European Union Qualified Person for Pharmacovigilance (QPPV), provides training and mentorship on pharmacovigilance strategies, and maintains compliance with applicable 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 completion of comparable post-medical-school clinical training relevant to the hiring country. US-trained physicians must be board eligible or certified.
• Foreign medical graduates hired for US-based jobs must meet the stated medical-school equivalency requirements; exceptions for US board eligibility or certification may be made at the discretion of the Chief Medical Officer.
• Minimum of 3 years of experience in the pharmaceutical industry or a clinical-care setting.
• Board certification in Cardiology.
• Fluent in English, with highly effective written and verbal communication skills.
• Strong clinical and diagnostic skills.
• Excellent interpersonal, organizational, and negotiation skills.
• Ability to manage multiple projects and work effectively in a fast-paced, matrixed environment.
• Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines.
• Ability to influence others across and within functions to create a positive working environment.
• Excellent teamwork skills.
• Knowledge of global pharmacovigilance guidelines, guidance, and regulations relevant to the role, including EMA and FDA requirements.
• Willingness to travel domestically and internationally as appropriate to support team business.

Nice To Haves

• Prior clinical-trial experience in academia or industry.
• Clinical development or pharmacovigilance experience.
• Knowledge of the drug-development process.
• Strategic thinking.
• Demonstrated success implementing projects or innovating.
• Receptive, engaging, and impactful contribution.

Responsibilities

• Provide GPS Medical leadership and proactive pharmacovigilance for assigned products.
• In early-phase development, perform or contribute to medical review of individual case safety reports for completeness and accuracy; provide company causality assessments and request follow-up when needed.
• Provide medical oversight of surveillance activities, safety signal decisions, and risk-management actions, including communication or escalation to appropriate stakeholders.
• Monitor safety activities for their impact on Core Safety Information and Core Risk Minimization activities.
• Build collaborative relationships, guide effective drug development, and ensure high-quality medical evaluation of safety data.
• Oversee and take action on regulatory queries concerning safety topics.
• Lead GPS Medical activities during acquisitions and integrations of companies or assets, supporting continuity of safety surveillance.
• Represent GPS Medical to internal and external stakeholders and build relationships with product and business leaders, regulatory teams, affiliate medical leadership, clinical research physicians, centers of excellence, discovery and clinical research teams, 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.
• As applicable, serve on safety advisory hub committees or consultative cross-functional bodies, providing safety input to clinical development teams.
• As applicable, participate in Quality-GPS safety surveillance teams assessing aggregate product complaint, adverse event, and device data for potential manufacturing-quality safety signals.
• Provide timely medical assessments and decisions on safety questions using current medical and scientific data in collaboration with cross-functional partners.
• Assess product safety, health hazards, and other risk documentation; provide clinical evaluation of individual adverse events for possible manufacturing-related root causes.
• Provide medical assessment for device design, development, risk management, and periodic reporting, as well as CMC development, manufacturing changes, submissions, and regulatory requests.
• Support anticounterfeiting activities, product shortage evaluations, quality-triage escalations, and regulatory reporting.
• Implement product safety assessment and health hazard evaluation processes with manufacturing or marketing partners.
• Prepare medical complaints in response to signals identified during adverse-event, product-complaint, and device surveillance.
• Review and approve or reject manufacturing investigation results in response to medical complaints and escalate identified manufacturing-related safety issues as needed.
• Monitor for unanticipated safety impacts related to deviations addressed by health hazard evaluations.
• Foster a collaborative Team Lilly culture focused on inclusion, innovation, acceleration, and delivery.
• Recruit, mentor, develop, and retain clinical, scientific, and drug-development talent, including clinical research physicians, clinical research scientists, and pharmacoepidemiologists.
• Ensure staff comply with company policies and procedures.
• Understand and support the QPPV role, including enabling the QPPV to fulfill legal responsibilities.
• Provide training, coaching, and mentorship on effective pharmacovigilance strategies and share expertise to advance GPS and enterprise goals.
• Maintain compliance with the Lilly Red Book, corporate policies, Lilly Research Laboratories and Global Patient Safety curricula, and the Lilly Corporate Integrity Agreement.
• Travel domestically and internationally as appropriate to support the team’s business.

Benefits

• Company bonus, dependent 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.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree