FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research, including the development and implementation of clinical trials, regulatory submissions, and data analysis. Possesses strong communication and interpersonal skills to effectively collaborate across functions and engage with key opinion leaders.
Highest-signal resume keywords
MD Or DO DegreeClinical Research ExperienceClinical Trial DesignRegulatory SubmissionsGood Clinical Practices (GCP)
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 Medical Data ReviewMedical MonitoringSafety ReviewStudy Concept DevelopmentData AnalysisClinical Study Report AuthoringRegulatory ComplianceElectronic Aggregate Data ReviewClinical Strategy TranslationPharmaceutical Product Development
Soft Skills
Strong Written CommunicationStrong Oral CommunicationInterpersonal SkillsProblem-Solving Abilities
Industry Keywords
Biopharmaceutical IndustryFDA RegulationsEMEA/CHMP GuidelinesCardiovascular IndicationsObesityDiabetesClinical DevelopmentProduct LifecycleCommercialization ProcessesGood Clinical Practices (GCP)
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide clinical/scientific knowledge for the development, design, delivery, and communication of the global evidence generation plan for the AMG 133 Phase 3 program
- Work cross-functionally to translate clinical strategy into study concept documents, protocols, and related documents
- Provide clinical input into and implement clinical trials
- Review clinical data and interpret results
- Serve as medical monitor for ongoing clinical trials
- Review and analyze clinical trial data for accuracy, completeness, protocol adherence, and regulatory compliance
- Participate in and provide clinical input into safety and regulatory interactions
- Author clinical study reports, publications, and regulatory submissions
- Develop relationships with key opinion leaders
- Make scientific presentations at advisory boards, scientific meetings, and external committee meetings
- Report directly to the Global Development Lead for cardiovascular indications
Requirements
What you’ll need- MD or DO degree from an accredited medical school
- 3 years of clinical research experience
- Three (3) or more years of clinical research experience in the biopharmaceutical industry preferred
- Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities preferred
- Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
- Experience developing study concepts for clinical development and clinical trial designs with cross-functional input in Phase 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications
- Experience with clinical trial medical data review, medical monitoring, and/or safety review and interpretation, including electronic aggregate data review tools
- Experience drafting high-level submission documents for regulatory submissions, including clinical regulatory responses
- Strong written and oral communication and presentation skills
- Strong interpersonal skills and problem-solving abilities
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
- Leadership experience or potential as a medical expert in a complex matrix environment
Benefits
Comp & perks- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Financial plans with opportunities to save towards retirement or other goals
- Work/life balance support