Spero Therapeutics Clinical Compliance Manager in Cambridge, Massachusetts
Spero Therapeutics (Nasdaq: SPRO) is a multi-asset clinical stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on the unmet needs of patients with multi-drug resistant (MDR) bacterial infections. Spero?s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide, formerly SPR994), is designed to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections. In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis. Spero is also advancing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero?s third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections.
We sincerely believe that our novel product candidates will have meaningful impact on patient health and significant commercial applications for the treatment of MDR infections in both the hospital and community settings.
General Scope and Summary of Role
The Manager, Clinical Compliance is responsible for supporting the Clinical Operations Department through SOP development and implementation and process improvement to maintain GCP compliance and ensuring an inspection-ready state. The Manager, Clinical Compliance will assist the Director, Clinical Compliance and Clinical Operations Leads with compliance-related issues and proactively provide support to ensure quality study deliverables. The Manager, Compliance Clinical is responsible for a broad scope of varying activities to support both department and corporate goals.
What You Will Do
Development, implementation, and maintenance of standard operating procedures (SOPs), work instructions (WIs), forms, and templates to define Clinical Operations processes to improve quality and promote consistency for Spero-sponsored clinical studies
Ensuring continuous inspection readiness according to FDA regulations and international regulations as applicable
Leading efforts in inspection preparation, including advising on inspection expectations, preparing for mock inspections, and general coordination and support activities during and following an inspection
Assisting with vendor and investigator oversight activities to ensure compliance with the study protocol and overall clinical objectives, including development of quality plans and working with Clinical Operations Leads on study-specific oversight plans and tools to ensure regulatory, clinical, and quality compliance
Ensuring that study documentation is maintained at Spero and partner CROs according to applicable regulations, industry accepted standards, and SOPs and working with Clinical Operations Leads to confirm audit-ready condition of clinical trial documentation while working to TMF best practices
Collaborating with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and Spero SOPs
May perform QC of study documents, such as study protocols
May be called on from time-to-time to engage in study-specific work such as monitoring report review
Travel requirement of 10% (domestic and international) as applicable for site and vendor oversight.
What You?ll Need
Advanced knowledge of ICH-GCP guidelines and FDA regulations as related to clinical research
High level of expertise in leading procedure (e.g. SOP) development activities within Clinical Operations
Experience managing study trial master files and knowledge of best practices as it relates to TMF management
Study/site management experience is not required, but is preferable
Critical thinker with ability to synthesize information from multiple sources
Strong oral and written communication skills
The candidate will work independently, with an ability to shift priorities, under general direction in a fast-paced environment
Preferred Education/Experience: bachelor?s degree with at least 5 years? experience in a GCP compliance-related role in a pharmaceutical or biotechnology company
Ideal candidate will have been involved in inspection preparation and participation
By joining our committed and highly motivated team, you will experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero?s culture is one that emphasizes ?servant leadership,? or putting ego aside and working for the benefit of the team and our patients. Our culture values our colleagues? opinions and celebrates accomplishments in service of patients.