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About the role
Key responsibilities & impact- Function as Clinical Scientist for a program and/or delegate of Therapeutic Area Clinical Scientist
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings
- Represent the function in collaborative activities with other departments
- Maintain proficient understanding of therapeutic disease areas, drug candidates, disease biology, clinical manifestations, therapeutic standards, mechanisms of action, and drug landscapes
- Propose, design, and execute clinical research and development studies for early- and late-stage assets
- Develop Expanded Synopses and author clinically relevant sections of clinical trial protocols and amendments
- Author or review medical monitoring plans, SAPs, informed consents, Clinical Study Reports, and regulatory documents
- Perform quality reviews, approve documents where appropriate, and resolve cross-functional comments
- Plan and prepare information for external and stakeholder meetings
- Present data and information to external investigators and internal collaborators
- Analyze how program objectives and study design impact data analysis
- Identify risks and design mitigation strategies
- Promote consistent first-line medical/clinical data review techniques across studies and programs
- Review clinical data review plans and author medical monitoring plans
Requirements
What you’ll need- Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/PharmD/MSc)
- ≥ 10 years of pharmaceutical clinical drug development experience
- Experience in Immunology clinical trials preferred
- Proficient knowledge of the drug development process, Good Clinical Practice, study design, and clinical research methodology
- Solid medical writing skills
- Experience in all aspects of conducting global clinical trials and execution of clinical programs
- Strong team-player capabilities
- Confidence and professional diplomacy when relating to people at all levels internally and externally
- Demonstrated ability to influence within a team and may influence cross-functionally in a matrix organization
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required
- Hybrid flexibility