Spero Therapeutics is a global multi-asset clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts dedicated to developing a novel and highly differentiated pipeline of antibacterials focused on unmet needs of patients with drug resistant bacterial infections. Spero’s lead product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections. Spero also has a platform technology known as its Potentiator Platform that it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial infection, a rare and often chronic fatal infection. We are looking for highly motivated people who thrive on being challenged and working in a highly collaborative environment to join the team and play a key role in conducting rigorous, cutting-edge science.
Join a small and enthusiastic team in a growing drug discovery company. Spero Therapeutics, Inc. is seeking a motivated and team-oriented individual who will be a key contributor to the overall success of Spero’s clinical development program.
The Manager/AD of Clinical Data Management will serve as the primary Data Management expert in a growing, multi-disciplinary team. The candidate will be responsible for the accuracy and completeness of clinical data output for clinical trials, and will have a thorough understanding of Data Management and Clinical Development processes and policies. S/he must be able to identify and solve complex problems across multiple studies with little supervision. The ideal candidate will be experienced in:
- Development and implementation of Data Management Operational Plans (DMOP) and Data Validation Plans.
- Development of data specifications and CRF design
- User Acceptance Testing of e-CRFs and other tools
- Establishing and maintaining clinical databases using standardized software packages
- Data handling, back-end query generation, data reconciliation
- Data coding (e.g. concomitant medications, adverse events) using standard international dictionaries, WHO and MedDRA.
- Application of regulatory submission standards (e.g. CDISC CDASH, ADaM, SDTM)
- Review and analysis of clinical data via ad hoc retrieval systems
- Development and implementation of validation systems for statistical output.
- Generation and QC of data output, including statistical tables, listings, and figures
- Maintenance of consistent data handling practices across studies
- Review and negotiate DM contracts; liaise with Data Management vendors
The candidate will coordinate process development initiatives and DM SOP reviews, and will have oversight of data management activities performed by external vendors. The candidate will also work with a team to determine, execute, review and advise on appropriate data management applications for new projects. SAS programming and/or biostatistics experience would be a plus.
Qualifications and Experience
- Qualified candidates will be enthusiastic, adaptable, and timeline-oriented, with a desire to manage external teams
- Knowledge of GCP and FDA regulatory requirements
- Excellent organizational ability are required
- Good oral and written communication skills
- The candidate will work in a fast-paced environment under general direction of the Head of Clinical Operations
- Preferred Education/Experience: Bachelor of Science with 5-9 years; Master of Science with 3-7 years
Spero has a vibrant and engaging culture of innovation and team work and we are continuing to build a top-tier team to rapidly advance our programs in a fast-paced, exciting and fun work environment. We offer a robust benefits package including premium health/dental plans, 401(k) retirement plan, incentive stock options, 4 weeks paid time off, professional development, and frequent social opportunities.
Please forward your CV/resume to Careers@sperotherapeutics.com
Spero Therapeutics, Inc. 675 Massachusetts Avenue, 14th Floor, Cambridge, MA 02139