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About the role
Key responsibilities & impact- Advise sponsors on product development strategy, protocol design, endpoint selection, and clinical trial feasibility for Phase I–IV programs
- Provide medical oversight and safety leadership for assigned clinical trials, including medical monitoring and safety review activities
- Support business development efforts through proposal review, budget input, and participation in sponsor and bid pursuit meetings
- Lead and support critical safety activities including SAE/SUSAR review, DSMBs, dose escalation meetings, and protocol deviation oversight
- Review and ensure scientific integrity and medical consistency across key trial documents including protocols, ICFs, CSRs, DSURs, and PSURs
- Mentor cross-functional teams and provide therapeutic expertise to internal stakeholders, investigators, and clients throughout study execution
Requirements
What you’ll need- MD or PhD required
- Minimum 5-10 years of relevant work experience, including at least 5 years of clinical development experience
- Infectious Disease expertise required
- Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
- GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements
Benefits
Comp & perks- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial designmedical monitoringsafety reviewprotocol deviation oversightSAE reviewSUSAR reviewdose escalation meetingsscientific integrity reviewmedical consistency reviewtherapeutic expertise
Soft Skills
mentoringleadershipcommunicationcollaborationadvisory skills
Certifications
MDPhDlocal/state/national medical license
