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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Pharmacology and the drug development process, with a strong focus on conducting and reporting global clinical trials. Proficient in regulatory compliance, patient safety, and collaboration with cross-functional teams to support clinical strategies and pharmacovigilance.
Highest-signal resume keywords
Clinical Pharmacology ExpertiseClinical Trial ManagementRegulatory CompliancePharmaceutical ExperienceInterpersonal Communication
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 Trial DesignData AnalysisProtocol DevelopmentPharmacovigilanceBiomarker QualificationPharmaceuticsProduct DesignClinical ResearchAdverse Event ReportingDrug Development Process
Soft Skills
Negotiation SkillsTeamwork SkillsOrganizational SkillsInfluencing SkillsCommunication Skills
Industry Keywords
GCPFDAINDClinical DevelopmentEpidemiologyToxicologyRegulatory AffairsMedical AffairsHealth SciencesClinical Pharmacology Submission
About the role
Key responsibilities & impact- Participate in development, conduct, and reporting of global clinical trials for new compounds
- Implement global clinical trials and report adverse events according to patient safety requirements
- Review protocols, study reports, publications, data dissemination materials, labels, grant submissions, and contracts
- Engage with regulatory and governmental agencies and external clinical customers, including thought leaders
- Work with basic research scientists to identify lead compounds and plan preclinical studies
- Support clinical pharmacology submission package planning with Business Unit teams
- Serve as a scientific resource for study teams and departments
- Ensure medical team activities comply with applicable regulations, GCPs, company standards, and policies
- Develop clinical strategies and plans for compounds, including Phase 2 and 3 and biopharm submission plans
- Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, and Tailored Therapeutics teams
- Design and oversee clinical pharmacology, biomarker qualification, and clinical research studies
- Develop protocols and study conduct documents
- Support investigator selection, study start-up, training, and site activities
- Provide scientific support to trial managers, monitors, investigators, and ethics boards
- Monitor patient safety and coordinate pharmacovigilance actions
- Oversee third-party organizations supporting study execution
- Address scientific questions from external healthcare professionals
- Participate in clinical trial registry activities, data analysis, final reports, and publications
- Present clinical trial results to corporate committees, regulatory agencies, and external organizations
- Support publication strategies, symposia, advisory boards, and healthcare professional meetings
- Prepare clinical reports and regulatory materials, including IND and Investigator Brochure medical sections
- Support FDA advisory committee hearings, label discussions, and regulatory issue resolution
- Develop scientifically excellent and innovative teams and organizational talent
- Provide pre- and post-launch business customer support
Requirements
What you’ll need- Life science degree (MD, PhD, PharmD) with requisite experience in Clinical Pharmacology
- PhD preferred but not required
- Experience in Pharmaceutics and Product Design preferred
- Knowledge of and experience in Clinical Pharmacology and the drug development process preferred
- Fluent in English, both written and verbal
- Interpersonal, organizational, and negotiation skills
- Ability to influence others cross-functionally and within the function
- Excellent teamwork skills
- Willingness to engage in domestic and international travel
- 3–5 years of clinical experience, or 3–5 years of pharmaceutical experience, including 2 years in clinical development
- Alternatively, a BS or Master's degree in a health, medical, scientific, or related field and 7–10 years of directly related pharmaceutical experience
- Clinical trial experience or experience relevant to drug discovery, drug/clinical development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs
- Evidence of direct contribution to medical content, where applicable
- Demonstrated ability to balance scientific and business priorities
- Demonstrated communication, interpersonal, teamwork, organizational, and negotiation skills
- Regular and consistent attendance
- Ability to sit for extended periods and operate a vehicle safely
- Ability to use various computer software
- Ability to perform light to moderate lifting and carrying up to 15–20 lbs
- Varied hours may be required
Benefits
Comp & perks- Remote work arrangement
- Domestic and international travel opportunities
- EEO and accommodations support