LOCATION: Los Angeles California
POSITION TYPE: Regular, Full-time
Reporting 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 Do - GCP Compliance
Plan, optimize, implement, manage, and continuously-improve Standard Operating Procedures (SOPs), processes, communication, and infrastructure within Clinical Operations
Work 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 efficiency
Ensure 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.
What You'll Need
Minimum 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 <25 %
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.