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About the role
Key responsibilities & impact- Partner with Medical Directors to design and deliver clinical studies and programs
- Contribute to program team meetings, advisory boards, steering committees, and data/safety monitoring meetings
- Build and maintain understanding of the disease area, drug candidate, mechanism of action, and drug landscape
- Assist with developing the Expanded Synopsis and author or review clinical sections of protocols, amendments, and study reports
- Author or review medical monitoring plans, SAPs, informed consents, and regulatory documents
- Perform clinical data review and safety monitoring across assigned studies
- Identify critical risks and recommend mitigations
- Promote consistent review practices and maintain compliance with FDA, EMEA, ICH, and GCP guidelines
- Influence across teams through clear, concise communication and creative problem-solving
- Collaborate with Medical Directors and cross-functional partners as a member of the Clinical Study Team and Global Clinical SubTeam
Requirements
What you’ll need- Advanced degree in life science or healthcare (PhD, MD, PharmD, or MSc)
- 8+ years of pharmaceutical clinical drug development experience
- Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology, and medical writing
- Strong analytical, presentation, interpersonal, and problem-solving skills
- Significant experience working cross-functionally, with strong organizational awareness
- Proven track record of clinical trial process improvements preferred
- Compliance with FDA, EMEA, ICH, and GCP guidelines
- Right to work and educational qualifications may be verified through background checks
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
