Manager/Senior Manager, Clinical Operations

About Edgewise Therapeutics:

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position:

Edgewise is headquartered in Boulder, Colorado and this is an on-site (preferred) or remote position for a growing Clinical Operations team. The assigned clinical studies 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).

Essential Job Duties and Functions:

• Provide operational expertise and strategic input for assigned clinical studies.
• 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.
• Participate in vendor evaluation and selection activities. In conjunction with Research & Development QA support site and/or vendor audits including resolution of findings. Assigned Department Representative responsible for Clinical Vendor relationship and management as applicable.
• 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 management and/or governance committees when warranted.
• Oversight/execution of site selection and start-up activities as needed for assigned clinical studies (e.g. essential document review, Site Qualification Visit (SQV) and Site Initiation Visit (SIV) deck creation/review, participate in SQV/SIV, collaborate with contracts team to ensure timely execution of CTAs and Amendments as applicable)
• Oversight of Edgewise CRAs assigned to clinical studies as applicable. Oversight/Approval of monitoring documents/plans and activities, including periodic review of outputs and actions related to monitoring. Perform or attend monitoring visits as needed for Sponsor representation.
• Development, review and approval of relevant study plans, as applicable.
• Study team meeting management and attendance; regular review of meeting agendas and minutes.
• Oversight of protocol deviation process for assigned study including review of individual protocol deviations, categorization and actions; primary purpose of review is to help identify trends across sites or the study.
• 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 electronic data capture (EDC) system UAT. Proactively review EDC to identify issues. Participate in data review and assist internal/external team members with data-related queries/requests.
• Participate in the development of IRT systems through reviewing system specifications and UAT in collaboration with Clinical Supply and Statistics.
• Oversight and support of TMF activities as required.
• Participate in monthly Safety and Compliance meetings by reviewing adverse events, drug accountability and protocol deviations.
• Contribute to drafting Standard Operating Procedures (SOPs) and adhere to department and study-specific processes to 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.

Required Education, Experience and Skills:

• B.S./B.A. in nursing, scientific or business-related field
• 7+ years of clinical operations experience in clinical trial design and conduct; 5+ years industry experience
• In-depth knowledge of clinical research operations, including GCP, FDA regulations, and ICH guidelines
• Proficiency in Electronic Data Capture and Clinical Trial Management Systems
• 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.
• Excellence in project management and communication.

Salary range: $130,000 - $180,000, title and salary commensurate with experience

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

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.