Clinical Operations Role (Manager/Sr. Manager/Ad)

Edgewise Therapeutics is a biotechnology company harnessing proven expertise and understanding of skeletal and cardiovascular muscle physiology to develop novel, transformative therapies for serious muscle diseases. Based in Boulder, Colorado, we have built a state-of-the-art muscle research facility to capitalize on new insights into the nature and consequences of muscle adaptation and injury with disease.

We offer an excellent compensation package including competitive base salary, discretionary bonus, company ownership and comprehensive benefits. Edgewise also offers the opportunity to be part of a small, collaborative, and passionate biotech team. To learn more, please go to www.edgewisetx.com.

About the Position:

Edgewise is headquartered in Boulder, Colorado and this is a remote position for a growing Clinical Operations team based in and around the east coast. The assigned clinical trials will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to lead/provide oversight for more than one study or across programs and be assigned direct report(s).

Primary Responsibilities:

• Support onboarding, mentor and manage direct reports within the department.
• Review and approval of relevant study plans, as applicable.
• Development and management of the study budget inclusive of site payment management and vendor invoicing.
• Participate in monthly Safety and Compliance meetings by reviewing adverse events, drug accountability and protocol deviations.
• 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.
• Study team meeting management and attendance; regular review of meeting agendas and minutes
• 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.
• Provide operational expertise and strategic input for assigned clinical trials.
• 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.
• Oversight of study timelines to ensure the needs of the clinical development plan are met.
• Provide strategic input and management of site activation activities and recruitment strategies.
• May collaborate with other functional leads to manage project related efforts. Participates in departmental quality or process improvement initiatives.
• Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring.
• Participate in the development of IRT systems through reviewing system specifications and UAT in collaboration with Clinical Supply and Statistics.
• Provide expertise and operational input into protocol synopsis, final protocol, Informed Consent, and other study related documents.
• Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.
• Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
• Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study.

Requirements:

• Excellence in project management and communication.
• Experience must include Phase 2 and 3 studies (globally recruited).
• Knowledge in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.
• Bachelor's Degree (Life Sciences)
• Experience in more than one therapeutic area is advantageous. Pediatric experience is a plus.
• 4-6 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.

Travel Requirements:

• Potential to meet as a dept. in and around New England up to monthly and to Boulder, Colorado as needed.

Salary range: $125,000 – $195,000, title and salary commensurate with experienc

If interested in this position, please apply at https://edgewisetx.com/join-our-team/ or apply via LinkedIn.

Edgewise is proud to be an equal opportunity employer. Our offers are contingent on background check and education verification.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.