Responsibilities
- Act as internal medical monitor or supervise medical monitoring for active clinical trials.
- Ensure all clinical study activities follow established governance, quality standards, regulatory guidelines, and maintain inspection-ready documentation.
- Evaluate patient eligibility, protocol deviations, adverse events, serious adverse events, lab results, and real-time study data.
- Take part in safety review meetings and assist communications with Data Monitoring Committees and regulatory bodies.
- Offer medical expertise and support to clinical investigators and trial sites.
- Lead the Clinical Development Team for designated rare bone disease programs.
- Provide clinical leadership and oversight for current global Phase 2 trials and help plan future late-phase studies.
- Manage cross-functional Clinical Development Teams and collaborate with departments including Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Pharmacology, and Data Management.
- Contribute to the overall clinical development strategy, product lifecycle planning, and regulatory engagement.
- Ensure global clinical trials are conducted with high quality and adherence to protocols.
- Write, review, or approve study documents such as protocols, manuals, monitoring plans, charters, training materials, consent forms, and clinical study reports, ensuring clarity, completeness, and operational practicality.
- Ensure consistency and quality across all clinical and regulatory documentation, including protocols, statistical plans, reports, and submissions.
- Work closely with Clinical Operations, CROs, and internal teams to maintain operational excellence and regulatory readiness.
- Lead efforts to resolve issues related to study execution, patient enrollment, data integrity, and protocol adherence.
- Support company interactions with regulatory agencies, clinical investigators, and key external experts.
- Represent the organization at scientific conferences, investigator meetings, and advisory board sessions as required.
Compensation
Competitive salary with comprehensive benefits package
Work Arrangement
Hybrid or remote options available
Team
Cross-functional clinical development environment
Other
- Up to 20% domestic travel
- Medical, dental, and vision coverage for employees and their eligible dependents
- 401(K) Retirement Plan with Company match
- Company paid Long Term Disability Coverage
- Company-paid life Insurance & AD&D Coverage
- Voluntary Life Insurance & AD&D Coverage
- Employee Assistance Program (EAP)
- Company-paid Holidays
- Vacation
- Paid Sick Leave
- Telecommunication Monthly Stipend
- Work-From-Home Equipment Reimbursement
Not specified
