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Director – Clinical Pharmacologist / Clinical Research Scientist
Eli Lilly and Company. Progress multiple early clinical assets into first-in-human studies or support further development through clinical pharmacology and mechanistic studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial design and execution, particularly in Phase 1 and Phase 2 studies, while ensuring compliance with regulatory requirements and patient safety protocols. Possesses strong communication and collaboration skills to effectively engage with cross-functional teams and external stakeholders.
Highest-signal resume keywords
Clinical Trial DesignRegulatory SubmissionsPharmacovigilancePatient Safety MonitoringAdvanced Health/Medical Degree
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical PharmacologyBiomarker QualificationData AnalysisProtocol DevelopmentClinical Strategy PlanningAdverse Event ReportingStudy Report PreparationInvestigator SelectionPhase 1 StudiesPhase 2 Studies
Soft Skills
Strong CommunicationInterpersonal SkillsOrganizational SkillsTeamworkNegotiation Skills
Certifications & Qualifications
PharmDPhDMSN
Industry Keywords
Clinical TrialsPharmaceutical IndustryPatient SafetyEthical ReviewClinical Research
About the role
Key responsibilities & impact- Progress multiple early clinical assets into first-in-human studies or support further development through clinical pharmacology and mechanistic studies
- Develop, conduct and report global clinical trials for new compounds
- Implement global clinical trials and report adverse events according to corporate patient safety requirements
- Review protocols, study reports, publications, data dissemination, labels, grant submissions, contracts and regulatory materials
- Plan clinical strategies and clinical development programs for regulatory submissions
- Support first-in-human dosing studies and biomarker plans
- Collaborate with Global Patient Safety, PK/PD, ADME, Statistics and Tailored Therapeutics teams
- Work with discovery research scientists on research strategies, candidate selection and pre-clinical development
- Design and oversee clinical pharmacology studies, biomarker qualification studies and protocol development
- Support study documents and collaborate with clinical research staff, statisticians, health outcomes scientists, consultants and investigators
- Participate in investigator identification and selection, study start-up meetings and investigator/site training
- Oversee ethical review, informed consent, regulatory approvals and study initiation requirements
- Serve as a resource to clinical trial managers, monitors, investigators and ethical review boards
- Monitor patient safety and implement pharmacovigilance actions
- Oversee partnerships with Third Party Organizations for study execution
- Address scientific questions from external health care professionals
- Participate in clinical trial registry activities, publication strategy, data analysis and final reports
- Present clinical trial results to corporate committees, regulatory agencies and external agencies
- Prepare clinical reports and regulatory submissions, including medical sections of INDs and Investigator Brochures
- Develop and retain a scientifically excellent workforce and foster inclusion, innovation and continual improvement
- Support medical strategies for brand commercialization, business development and strategic brand planning
- Maintain relationships with external experts and opinion leaders and support business-to-business and business-to-government activities
Requirements
What you’ll need- An advanced health/medical/scientific graduate degree (e.g., Pharmacology, physiology, microbiology) or a related graduate degree (e.g., PharmD, PhD, MSN) with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
- 3 years of pharmaceutical industry experience, or similar, relevant to clinical trial design and conduct of Phase 1 or Phase 2 studies
- 3 years of clinical practice experience
- Fluent in English, both written and verbal communications
- Strong communication, interpersonal, organizational, teamwork and negotiation skills
- Ability to influence others within teams and in a matrix environment
- Ability to engage in domestic and international travel as appropriate to support the business of the team
Benefits
Comp & perks- Company bonus depending in part 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
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities