Note: The job is a remote job and is open to candidates in USA. Edgewise Therapeutics is dedicated to discovering new medicines that enhance the lives of patients with serious muscle diseases. They are seeking an Associate Director of Clinical Development to provide operational expertise and strategic input for complex clinical trials, manage study budgets, and oversee site activation and recruitment strategies.
Responsibilities
- Provide operational expertise and strategic input for assigned clinical trials
- Provide expertise and operational input into protocol synopsis, final protocol, Informed Consent, and other study related documents
- Development and management of the study budget inclusive of site payment management and vendor invoicing
- Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy
- Provide strategic input and management of site activation activities and recruitment strategies
- Oversight of study timelines to ensure the needs of the clinical development plan are met
- Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
- Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring
- Review and approval of relevant study plans, as applicable
- Study team meeting management and attendance; regular review of meeting agendas and minutes
- Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study
- Document review and monitoring of risks and decisions at the study level and implementation of mitigation strategies
- In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR
- Participate in the development of IRT systems through reviewing system specifications and UAT in collaboration with Clinical Supply and Statistics
- Participate in monthly Safety and Compliance meetings by reviewing adverse events, drug accountability and protocol deviations
- Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections
- Support onboarding, mentor and manage direct reports within the department
- May collaborate with other functional leads to manage project related efforts. Participate in departmental quality or process improvement initiatives
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures
- Perform other duties as assigned by supervisor
Skills
- Bachelor's Degree (Life Sciences)
- 6+ years' experience in pharmaceutical industry or clinical research organization, including 2+ years clinical study management with a minimum of 2 years at a biotech or pharmaceutical company
- Experience must include Phase 2 and 3 studies (globally recruited)
- Experience in more than one therapeutic area is advantageous. Rare/Orphan disease and cardiac experience is a plus
- Knowledge in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP
- Excellence in project management and communication
Benefits
- Health benefits
- A discretionary bonus plan
- Stock option grants
- A stock purchase plan
- A 401(k) with match
- Paid time off
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