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Senior Director, Clinical Compliance

Company: Spero Therapeutics
Location: Cambridge
Posted on: May 14, 2022

Job Description:

Senior Director, Clinical ComplianceJob LocationsUS-MA-Cambridge - USID2021-1047CategoryClinical OperationsPosition TypeRegular Full-TimeAbout Us Spero Therapeutics (Nasdaq: SPRO) is a multi-asset pre-commercial 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 patients' unmet needs with multi-drug resistant (MDR) bacterial infections. Spero's lead product candidate, tebipenem HBr, is an oral carbapenembeing developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). InSeptember 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP, and in October 2021, Spero filed a new drug application for tebipenem HBr in these indications.Spero is also developing 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 believe that our novel product candidates will have a meaningful impact on patient health and significant commercial applications for treating MDR infections in hospitals and community settings.OverviewReporting to the VP, Head of Clinical Operations, the Director of Clinical Compliance oversees strategic and tactical operations related to two key foci: 1) GCP Compliance and 2) Clinical Supply / Unblinded Clinical Operations. The Director of Clinical Compliance provides management oversight to direct reports and department-wide mentorship.What you'll doGCP COMPLIANCEPlan, optimize, implement, manage, and continuously-improve Standard Operating Procedures (SOPs), processes, communication, and infrastructure within Clinical OperationsWork with the Head of Clinical Operations to support timely and in-budget completion of department goals by ensuring compliance and continuity as follows:Lead departmental initiatives aimed at innovation, process improvement, and efficiency (e.g. eTMF implementation)Facilitate cross functional process improvement initiatives (e.g., liaising with IT to support IT systems and technology-related improvements)Establish key vendor oversight plans and processes (e.g., Clinical Study Oversight Plan, Co-monitoring, toolkit, etc.) Collaborate with Clinical Operations Leads to establish performance and quality metrics for the study, and report metrics and that drive quality and efficiencyEnsure state of inspection readiness:Oversee GCP Inspection Management activities ensuring appropriate training and tools are in place for the Clinical Operations organization. Lead internal Sponsor inspection-readiness working groups for all programs, ensuring storyboards are created and risk areas are documented, mitigated, and escalated. This is a cross-functional activity, including representation from Clinical Operations, Clinical Development, Pharmacovigilance and other areas as indicated.Contribute to GCP Inspection Readiness Steering Committee.Develop strategy for inclusion of Vendors/CROs in Sponsor inspection-readiness. Drive and organize Q&A sessions for the Clinical Operations organization.Support Investigator Sites in Inspection Preparation activities and/or actual Health Authority inspections in collaboration with Quality Assurance. May travel to investigative sites for this purpose.Contribute to the review and follow-up of GCP inspection findings. Create an effective interface with Quality Assurance to ensure GCP compliance across the clinical operations organization, including:Actively engage with QA to ensure vendors and clinical sites are audited regularly and develop strategic audits as they relate to clinical studiesContribute to audit strategy during vendor selection and use a risk-based approach to identify sites for auditCoordinate audit scope (pre-audit) and post-audit activities with relevant Clinical Study Team members and stakeholdersAttend Audit Debriefs for Investigator Site Audits, GCP Vendor/CRO audits, and Clinical Operations internal audits.Review Audit ReportsSupport Clinical Operations in managing activities associated with Audits: As needed, assist the clinical trial teams in responding to audit findings, ensuring appropriate root cause is performed and CAPAs are created. Ensure all items are documented appropriately. Escalate audit observations that are critical or of significant safety impact Contribute to identification of relevant audit trends and implementing process changes to address any gapsReview audit metrics prepared by Quality and work with Clinical Operations and Quality to identify additional training needs and/or Process Improvement activities.Function as GCP Risk Facilitator, ensuring risks to clinical trial activities are documented, mitigated and escalated as appropriate.Stay current with new and revised regulations and trends in industry standard and serve as a GCP subject matter expert and provide guidance to internal Clinical Operations organization. This may involve attending industry conferences.Manage direct reports to support professional development and timely completion of goalsEnsure GCP compliance by providing guidance and support to Clinical Operations Leads and Clinical Study TeamsCLINICAL SUPPLY / UNBLINDED CLINICAL OPERATIONS Serve as unblinded project lead on double-blinded clinical studies (including development and review of all plans as they relate to unblinded activities; set-up of IRT system; pharmacy manual development; contact with unblinded CRO and site personnel as required; review of unblinded documentation such as drug accountability logs; review of unblinded monitoring reports)Ensure availability and adequate quantity of clinical trial material for clinical studiesWork with QA to ensure timely release of clinical trial material and delivery to clinical trial sitesWhat you'll needMinimum of 10+ years industry experience in a Clinical Quality Assurance or Clinical Compliance role.Strong working knowledge of FDA, EU, and other global regulations and ICH GCP E6 (R2) and other guidance documents governing GCP.Experience conducting GCP inspection readiness activities and/or hosting EMA and/or FDA inspections.Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.Independently motivated, detail-oriented and strong problem-solving ability.Excellent organizational skills, ability to multi-task in an extremely fast-paced environment with changing priorities.Excellent verbal and written communication skills.Experience in a start-up environment preferred. Proven track record of effective leadership.Must be pro-active team player, flexible, and open to change.Experienced in multiple phases of research preferred.Travel: national and international By joining our committed and highly motivated team, you'll 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, and values our colleagues' opinions and celebrates accomplishments in service of patients. As a federal contractor, Spero Therapeutics is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason or genuine religious belief relating to vaccinations. All employees must be in compliance with Spero Therapeutics' COVID-19 vaccine policy prior to the commencement of their employment.Spero Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Keywords: Spero Therapeutics, Cambridge , Senior Director, Clinical Compliance, Executive , Cambridge, Massachusetts

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