Spero Therapeutics is looking for a collaborative and enthusiastic partner to join our Finance team. This role will participate in many aspects of finance for the company with a focus on budget/forecast preparation, consolidation, and internal reporting. This individual will partner with key stakeholders with an emphasis on maintaining transparency with the forecast and managing budget and forecast accuracy.  In addition, the candidate will be a contributor across the finance organization and assist the accounting team with month-end close activities.  

The Director of Statistical Programming will be responsible for providing statistical programming support to all clinical development programs. In addition to work as a hands-on programmer for various internal requests, this individual will also need to direct, guide, and validate CRO programming team or internal consultants’ programming work, and work collaboratively with internal and external teams in results reporting and regulatory submissions.

  Spero Therapeutics is looking for a collaborative, enthusiastic Program Manager. This individual will work closely with the Program Team Lead and the cross-functional program team to convert strategic objectives into operational project plans and to meet the goals/timelines for those projects. This role offers the opportunity to be an integral part of the Spero team by contributing to key programs in the company’s portfolio.  

Spero Therapeutics is looking for an experienced, collaborative, enthusiastic partner responsible for ensuring the robust application of traditional and emerging statistical methodologies to support the development and execution of clinical development strategies that deliver medically differentiated therapies that provide meaningful improvement to patients. In this role, the individual will provide strategic statistical input to the design, execution, analysis, and reporting of data for clinical and nonclinical studies and regulatory submissions across all Spero programs. Working in a cross-functional manner, this individual will liaise with various internal groups (Clinical, Nonclinical, Microbiology, Regulatory Affairs, Pharmacovigilance, and Medical Affairs) and external partners, including vendors and CROs for the delivery of statistics and data programming needs.

The Senior Manager, Clinical Data Management will have diverse data management and clinical trial experiences, be hands-on and motivated to support and contribute broadly to Data Management functional initiatives, and actively participate in the development, implementation, and management of data collection, ensuring its highest quality and integrity. Motivated and willing to work in partnership, guide and support cross-functional teams, and apply dynamic and creative approaches in the lifecycle of clinical trial data.

The Quality Assurance (QA) Manager will assist with the propagation and implementation of the Good Manufacturing Practices (GMP) Quality processes. The candidate will provide hands-on support for QA activities related to clinical supply products. The individual will work cross-functionally across the internal CMC and Regulatory teams and with external counterparts within the contract organizations. 

The Quality Assurance Senior Manager is responsible for proactively promoting compliance to Good Clinical Practice (GCP) regulations by providing Clinical and Research Development teams compliance guidance support related to GCP global regulations and guidelines. Additionally, the Quality Assurance Senior Manager applies established knowledge and experience with GCP regulations, guidelines, and local legislation to the auditing process to identify compliance issues associated with the conduct of clinical trials.

The individual is responsible for the day-to-day operations within the QC group in compliance with current GMP regulations and policies (FDA, ICH, EMA, etc.). The Quality Control Manager contributes to Clinical stage activities including QC testing in support of raw materials, in-process, drug substance, and finished products release and stability testing of small-molecule drug substance, drug product, intermediates, excipients, and packaging materials and components.

The Senior Clinical Project Manager (Sr. CPM) is responsible for the successful execution of clinical trials from protocol concept through clinical study report, ensuring completion of high quality and timely study deliverables. The Sr. CPM is a key contributor to the overall success of Spero’s clinical development program and is responsible for managing cross functional leadership and CRO/vendor management related to clinical trial operations. The Sr. CPM will primarily work on studies with high complexity (in terms of design, location, phase, etc.), and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. The Sr. CPM assures that the study is conducted per protocol, per business requirements (e.g., timing and budget), and in accordance with applicable regulations and guidance. The Sr. CPM is responsible for a broad scope of varying activities to support both department and corporate goals.

The Senior Director, DMPK, Bioanalysis, and Clinical Pharmacology, will report to the SVP, Clinical Development, with assigned responsibility to provide support to the Project Team Leaders. This individual will provide strategic guidance for the Phase 1 development programs and with Clinical Operations and the Project Team Leaders will be accountable for delivering clinical studies to agreed timelines and budget. This individual will supervise other Clinical Pharmacology, DMPK, and/or Bioanalysis consultants to ensure timely delivery of studies and documents.