Director - Clinical Research Physician, GPS Medical - Infectious Disease

Eli Lilly and Company•Us, IN

3d•$201,000 - $360,800

About The Position

The Clinical Research Physician (CRP) in Global Patient Safety (GPS) Medical leads and oversees the safety program for one or more assets throughout their product life cycles. The role coordinates technical functions within GPS and partners with integrated development or product teams to meet safety commitments. The CRP represents Lilly GPS Medical to internal and external stakeholders in accordance with corporate guidelines, standards, and policies. Specific responsibilities are agreed upon for each product or project. The position provides medical leadership for proactive pharmacovigilance, safety surveillance, signal decisions, risk management, safety assessments, and regulatory responses. It evaluates safety data and translates complex technical information into actionable insights and strategic discussions. The CRP also supports product safety work involving devices, manufacturing, quality issues, and regulatory reporting, and may represent GPS Medical in audits, inspections, committees, and cross-functional teams. The role includes people leadership and development, including recruiting, mentoring, and retaining clinical and scientific talent, as well as supporting the European Union Qualified Person for Pharmacovigilance (QPPV). The CRP provides training and coaching in pharmacovigilance and maintains compliance with applicable company policies, curricula, and the Lilly 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 country of hiring. U.S.-trained physicians must be board eligible or certified.
For U.S.-based roles, foreign medical graduates who are not U.S. board eligible or certified may be hired at the discretion of the Chief Medical Officer.
For non-U.S.-trained physicians, medical education and training must meet 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 Infectious Disease.
Fluent English and highly effective written and verbal communication skills.
Strong clinical and diagnostic skills.
Excellent interpersonal, organizational, and negotiation skills.
Ability to manage multiple projects in a fast-paced, matrixed environment and rapidly reprioritize to meet tight deadlines.
Ability to influence others across and within functions to create a positive working environment.
Excellent teamwork skills.
Willingness to travel domestically and internationally as needed to support the team’s business.
Knowledge of global pharmacovigilance guidelines 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 contribution.

Nice To Haves

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

Responsibilities

Lead and ensure proactive pharmacovigilance and safety oversight for assigned products, including medical review of individual case safety reports in early development.
Oversee safety surveillance, safety signal decisions, and risk management actions, and communicate or escalate issues to appropriate stakeholders.
Monitor safety activities for impacts on Core Safety Information and Core Risk Minimization activities.
Build collaborative relationships and guide effective, efficient 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, ensuring continuity of safety surveillance.
Represent GPS Medical to internal and external stakeholders, including product teams, business leadership, regulatory partners, affiliate medical leadership, research physicians, centers of excellence, and external opinion leaders.
Review and comment on external regulatory policies and trends affecting Global Patient Safety.
Represent GPS Medical in inspections and audits for assigned programs.
Contribute to safety advisory committees and cross-functional bodies, as needed.
Provide medical assessments for Product Safety Assessments, Health Hazard Evaluations, and other risk assessment documentation.
Assess safety matters involving device design and development, risk management, periodic reporting, CMC development and manufacturing, regulatory submissions and requests, anticounterfeiting, product shortages, quality escalation, and regulatory reporting.
Clinically evaluate individual adverse events for possible manufacturing-related root causes.
Implement the Product Safety Assessment and Health Hazard Evaluation processes with manufacturing or marketing partners.
Prepare medical complaints related to signals identified through adverse-event, product-complaint, and device surveillance; review manufacturing investigation results and escalate identified safety issues as appropriate.
Monitor for unanticipated safety impacts related to deviations addressed through Health Hazard Evaluations.
Foster a collaborative, inclusive, innovative, and delivery-focused team environment.
Recruit, mentor, develop, and retain clinical, scientific, and drug-development talent, and ensure staff compliance with company policies and procedures.
Support the QPPV role and help ensure the Qualified Person can fulfill legal responsibilities.
Provide pharmacovigilance training, coaching, and mentorship.
Maintain compliance with the Lilly Red Book, corporate policies, Lilly Research Laboratories and Global Patient Safety curricula, and the Lilly Corporate Integrity Agreement.

Benefits

Company bonus eligibility, 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.
Certain 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.