What are the responsibilities and job description for the Senior Director Medical and Safety position at Inozyme Pharma?
Position Overview :
Under the supervision of the SVP Clinical Development / CMO the Senior Director Medical and Safety will perform a key role in the continuing clinical development of INZ701 in collaboration with his / her cross functional colleagues and be accountable for implementing and managing all pharmacovigilance related activities and support clinical development activities. The Senior Director Medical and Safety will also monitor and document safety data to identify trends and potential safety signals / issues within and across all clinical studies and populations. As part of the execution of Inozyme strategy, he / she will work closely with Regulatory, Clinical Operations, Biostatistics and external vendors responsible for pharmacovigilance clinical development related activities.
Reporting Relationship : This position will report to the Senior Vice President, Clinical Development
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 :
- Broad remit across risk management, signal detection and periodic reporting consistent with relevant regulations, legislation and guidelines
- Leads internal safety meetings and ensures prompt response to requests for further information or queries received from Regulatory Agencies
- Maintains and optimizes PV procedures, including vendor oversight, compliance and quality checks
- Contributes to the preparation of PV related documents [DSUR, SMP, CCDS, IB, ICF) for internal and external purposes
- Participates in audits and inspections and contributes to the development of corrective and preventative actions, as necessary
- Contributes to briefing packages for regulatory meetings and responses to questions and participates in Regulatory meetings
- Provides input on clinical trial strategy and contributes to the development of clinical protocols and associated documents
- Provides medical monitoring activities including responding to medical questions from clinical trial sites and participating in investigator meetings, site initiation visits and safety committees
- Participates in medical and safety review of study specific and aggregated data in ongoing trials, e.g., safety and statistical outputs
- Supports development of Clinical Study Reports (CSRs)
- Supports Med Affairs in KOL management, preparation of publications and advisory boards
Educational Qualifications :
Additional Qualifications :
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