If you are interested in any of the open positions below, please contact us at careers@inozyme.com.
Position Overview:
The Director of Clinical Data Management will be responsible for the oversight of CDM activities outsourced to CROs, from study startup through study closeout. The individual would also be responsible for the development and implementation of clinical data management strategies and processes to enable the delivery of data capture, review and reporting systems that facilitate timely availability of actionable data to enable fast and efficient drug development. May have line management responsibilities.
Reporting Relationship: This person will report to the VP, Biometrics
About Inozyme Pharma:
Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).
Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.
Essential Duties and Responsibilities:
- Provide Clinical Data Management oversight of CRO and other external data vendors and ensure adherence to agreed project timelines and budgets.
- Provide leadership and expertise in data management ensuring data quality and regulatory compliance/
- Manage vendor relationships or partnerships from a Clinical Data Management perspective.
- Ensure the delivery of quality data by partnering with CROs and external vendors to develop and execute efficient quality data processes.
- Developing strategies for and implementing ongoing improvements within Clinical Data Management to ensure the quality and integrity of the clinical data from Inozyme Clinical trials.
- Perform hands-on clinical data management study activities, including the development of case report forms (CRF).
- Determines the appropriate and effective use of data management information and system tools for data and report retrieval, data listing review, error detection and production of standard displays to ensure quality data.
- Identifies opportunities, and implements solutions to globalize and standardize methods, processes, procedures, systems and templates in accordance with CDISC/SDTM requirements and industry best practices.
- Develop, review and implement Clinical Data Management processes, policies and SOPs.
- Participate in technology provider and Clinical vendor qualifications and audits.
- Support study-level/program audit and inspection readiness activities as needed.
- Train and mentor members of the clinical trial team form other functions on processes, projects, systems and programs.
- Lead data management support of submission activities.
- Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences.
- Line-Management responsibilities, if required.
Educational Qualifications:
- Bachelor’s degree, preferably in a scientific or engineering discipline such as Physical & Life Sciences, Statistics, Mathematics, Computer Science, IT, Biology.
- 10+ years working in clinical data management, with experience building data management functions and developing initiatives designed to promote efficiency and productivity.
- Extensive knowledge of clinical data management outsourcing models including functional-service providers and full-service CROs
- Experience leading and overseeing teams to ensure the timely provision of DM deliverables.
- Advanced hands-on knowledge of data management processes and systems.
- Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA, FDA requirements)
- Strong project management skills, and ability to effectively lead and collaborate with various business functions.
- Demonstrated ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects.
- Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.
- CDASH, CDISC & SDTM experience.
- Demonstrated ability to influence without authority.
- Demonstrate initiative, sound judgment and flexibility.
- Solid understanding of clinical drug development processes.
- Experience with PROs and eCOA data
Additional Qualifications:
- Experience with data visualization, analytics and reporting tools
- Experience programming in R, SAS, Python or other languages
Position Overview:
Responsible for overseeing statistical programming activities for multiple clinical studies and performing quality review of CRO/Vendor SAS programs and deliverables. The individual will also perform programming analyses to generate ad-hoc requests for publications, presentations and responses to regulatory agencies requests.
Reporting Relationship: This role will report into the VP, Biomtetrics
About Inozyme Pharma:
Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).
Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.
Essential Duties and Responsibilities:
- Oversee CROs or Programming vendors to ensure programming high-quality deliverables.
- Review CRO/Vendor deliverables consisting of SDTM and ADaM specifications, P21 validation reports (or equivalent), SDTM and ADaM Reviewer’s Guides, aCRFs, Define.xml files, analysis metadata report and executable programs for CRT packages.
- Develop and validate programs that generate SDTM and ADaM datasets, tables, listings, figures (TLF) in response to regulatory agencies requests, publication requests, and ad-hoc analyses.
- Program, or oversee programming of, quality review checks and reports for use by Clinical Data Managers, Medical Monitors and other study team members.
- Review and provide input into data acquisition and collection strategies/databases (to ensure CDISC compliance) and Statistical Analysis Plans with corresponding TLF shells.
- Collaborating across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications, and computing environment support.
- Evaluating, developing, revising, implementing, and ensuring compliance with functional guidelines, policies, and SOPs.
- Submission planning for BLAs and keeping abreast in changing regulatory data standard requirements.
Desired Skills & Experience:
- 10+ years statistical programming experience in the CRO or Pharmaceutical Industry.
- 7+ years people and/or project management experience in the CRO or Pharmaceutical Industry
- BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree
- Advanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.
- Familiarity with validation tools, Pinnacle 21.
- Solid understanding of data collection and database concepts including data collection processes in clinical trials.
- Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
- Experience in submissions to regulatory authorities.
- Thorough understanding of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.
- Thorough understanding of industry standards such as CDISC data standards and controlled terminology, FDA guidance such as 21 CRF Part 11 and data standard requirements and ICH.
- Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment.
- Strong project management skills.
- Skilled in resolving issues, suggesting process improvements, and effectively completing them.
- Excellent verbal and written communication skills in a global environment.
- Proven ability to work with cross-functional teams, specifically Data Management, Biostatistics, Clinical Operations, Pharmacovigilance and Medical Affairs to initiate, lead, and implement new initiatives and process improvements.
