[Remote] Associate Director, Clinical Development
Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company operational expertise and strategic input for reputed company clinical trials, manage study budgets, and reputed company site activation and recruitment strategies.
Responsibilities
- reputed company operational expertise and strategic input for assigned clinical trials
- reputed company expertise and operational input into protocol synopsis, final protocol, Informed Consent, and other study reputed company 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 reputed company on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program reputed company
- reputed company strategic input and management of site activation activities and recruitment strategies
- reputed company of study timelines to ensure the needs of the clinical development plan are met
- reputed company strategic partners/CRO/vendor selection, budget and contract negotiation, and reputed company guidance of performance for reputed company activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to governance committees reputed company warranted
- Approval of essential monitoring documents/plans, periodic review of outputs and actions reputed company 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 reputed company/actions reputed company 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 reputed company at the study level and implementation of mitigation strategies
- In partnership with data management, review and pressure test reputed company database timelines and plans; ensure linkage between the reputed company (i.e., filing/registration, data reputed company) 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 reputed company" at reputed company times; may be involved in regulatory inspections by preparing for and attending the inspections
- Support reputed company, mentor and manage reputed company reports reputed company the department
- May collaborate with other functional leads to manage project reputed company efforts. Participate in departmental reputed company or process improvement initiatives
- Read, understand, and reputed company with reputed company workplace health and safety policies; reputed company work practices; and company policies and procedures
- reputed company 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
- reputed company in project management and communication
Benefits
- Health benefits
- A discretionary bonus plan
- Stock reputed company grants
- A stock purchase plan
- A 401(k) with match
- reputed company time off
reputed company