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’re building a passionate, experienced team committed to tackling complex challenges and delivering meaningful outcomes for patients. If you’re looking to do work that matters, we’d love to hear from you.

About the Position:

Edgewise is headquartered in Boulder, Colorado and this is an on-site (preferred) or position for a growing Clinical Development 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 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.

Required Education, Experience and 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.

Salary range: $170,000 - $200,000, 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.

Learn more about this Employer on their Career Site

Associate Director, Clinical Operations