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Executive Director – Clinical Research Physician
Eli Lilly and Company. Lead development, management, execution, and oversight of safety programs for assigned assets throughout their product life cycles .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance, medical assessment, and regulatory compliance, with a strong foundation in clinical development and drug safety. Proven ability to lead cross-functional teams and synthesize complex data into actionable insights while maintaining effective communication with stakeholders.
Highest-signal resume keywords
Medical Doctor or Doctor of OsteopathyPharmacovigilance ExperienceClinical Development KnowledgeRegulatory Compliance ExpertiseStrong Clinical/Diagnostic Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacovigilanceMedical ReviewRisk ManagementData SynthesisAdverse Event EvaluationClinical Trial ExperienceDrug Development Process KnowledgeHealth Hazard EvaluationRegulatory ReportingQuality Triage
Soft Skills
Effective CommunicationInterpersonal SkillsOrganizational SkillsNegotiation SkillsTeamwork
Certifications & Qualifications
Board Eligible or Certified in Specialty/Subspecialty
Industry Keywords
Global Patient SafetyEMA GuidelinesFDA RegulationsClinical ResearchProduct Safety Assessments
About the role
Key responsibilities & impact- Lead development, management, execution, and oversight of safety programs for assigned assets throughout their product life cycles
- Coordinate technical functions within GPS and partner with integrated development or product teams
- Provide proactive pharmacovigilance and medical review of individual case safety reports
- Oversee surveillance activities, safety signal decisions, risk management actions, and regulatory safety queries
- Lead GPS Medical activities during acquisitions and integrations of new companies or assets
- Synthesize complex data into actionable insights and translate technical issues into strategic discussions
- Represent Lilly GPS Medical to internal and external stakeholders, including product, business, regulatory, affiliate medical, clinical research, and external opinion leaders
- Review external regulatory policy and trends affecting Global Patient Safety
- Represent GPS Medical in inspections and audits
- Provide medical assessment and decision-making for product safety assessments, health hazard evaluations, device risk management, CMC activities, anticounterfeiting, product shortages, quality triage, and regulatory reporting
- Evaluate adverse events for possible manufacturing-related root causes
- Implement PSA/HHE processes with manufacturing and marketing partners
- Prepare medical complaints and review or approve manufacturing investigation results
- Monitor unanticipated safety impacts related to deviations addressed by HHEs
- Foster a collaborative Team Lilly environment
- Recruit, mentor, develop, and retain clinical, scientific, and drug development talent
- Ensure staff compliance with company policies and procedures
- Support the European Union Qualified Person (QPPV) in fulfilling legal responsibilities
- Provide training, coaching, and mentorship on pharmacovigilance strategies
- Maintain compliance with Lilly policies, curricula, and Corporate Integrity Agreement
Requirements
What you’ll need- Medical Doctor or Doctor of Osteopathy
- Must be board eligible or certified in the appropriate specialty/subspecialty, or have completed comparable post-medical-school clinical training relevant to the country of hiring
- US-trained physicians must have achieved board eligibility or certification
- Foreign medical graduates in US-based jobs who are not US board eligible or certified may be hired at the discretion of the Chief Medical Officer
- Non-US-trained physicians must have completed education and training at a medical school meeting minimum requirements substantially equivalent to LCME-accredited medical schools
- Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting
- Prior clinical trial experience preferred
- Clinical development or pharmacovigilance experience preferred
- Knowledge of the drug development process
- Fluent in English with highly effective written and verbal communication skills
- Strong clinical/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 cross-functionally and within the function
- Excellent teamwork skills
- Willingness to engage in domestic and international travel as appropriate
- Knowledge of global pharmacovigilance guidelines, guidance, and regulations, including EMA and FDA
- Strategic thinking
- Demonstrated success implementing projects and/or innovating
- Receptive, engaging, and impactful contributor
Benefits
Comp & perks- Company bonus depending on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- 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 employee assistance program, fitness benefits, and employee clubs and activities