Leads the cross-functional Trial Team (CTT); tracking of project deliverables & timelines.
Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs)
Accountable for the delivery of the trial within agreed/projected life of trial budget.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.
Oversee end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases.
Ensure global compliance with pharmacovigilance regulations, including timely ICSR submission, high-quality case processing, and support for aggregate reporting.
Provide oversight and support of the PV vendor activities, including but not limited to the establishment and monitoring key performance indicators (KPIs) and vendor audits.
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. They were founded to develop a better way to treat the cellular drivers of tumor growth and committed to fair and equitable compensation practices.
Provide advanced toxicological analysis and consulting across human health risk assessment, chemical exposure, product safety, and regulatory compliance.
Critically review, interpret, and synthesise toxicological data, exposure assessments, and risk evaluations.
Serve as a senior subject matter expert supporting litigation, regulatory submissions, and complex technical evaluations.
J.S. Held is a global consulting firm that combines technical, scientific, financial, and strategic expertise to advise clients seeking to realize value and mitigate risk. The firm provides a comprehensive suite of services, products, and data that enable clients to navigate complex, contentious, and often catastrophic situations.