Janssen Research & Development is a leader in developing bio-therapeutics, biologic solutions for the treatment of challenging and complex diseases. We take unique approaches to exploring and developing new preventive and therapeutic platforms to treat unmet medical needs, including the development of recombinant vector vaccines, CAR-T cells and cell therapy applications.
In addition, the medical aspects and biologicals are subject to specific requirements related to e.g. gene therapy, advanced therapies, and genetically modified organisms (GMO). While the legal requirements are specific for each territory, in all cases a core scientific information package informing a detailed biological (environmental) risk assessment is required.
Under the direction of the Global Director, Environmental Product Compliance & Sustainability, the Sr. Principal will ensure oversight of biosafety requirements from early development to post-licensing as needed:
- Lead the Environmental Risk Assessment (ERA) and associated documentation (Annex III A & SNIF, Common application forms etc.) required to make GMO applications in the EU for Janssen, assuring compliance with Global Clinical Trial requirements;
- Support the Global Licensing Application (Market Authorization Application – MAA) requirements for biologicals;
- Keep overview and act as point of contact for the relevant product/non-clinical Biosafety expertise to project teams and clinical trial sites as required (for the latter to work with Global Clinical Development Organization, GCDO) during the development and marketing authorization of biologicals and any post licensing modifications that require biosafety and ERA re-assessment;
- Provide support throughout the lifecycle of the product to ensure consistency of biosafety elements;
- Coordinate and drive the scientific writing and maintenance (responses to questions upon application, modification of the GMO product, re-application of all ERAs & associated documents for biologicals of Janssen).
This leader will work closely with various internal (e.g. GMO working group, global regulatory affairs, biosafety officers at the sites) and external (CROs, consultants, expert groups) stakeholders.
• Take up the role of Subject Matter Expert (SME) for ERAs of biologicals;
• Participate in the internal GMO working groups to pro-actively identify the ERA needs for new medicinal products;
• For Clinical Trials (CTs), provide expert opinion on how CTs with specific biologicals are handled in target countries (e.g. whether they are handled under contained use or deliberate release of genetically modified organisms) and how this impacts the development process;
• Coordinate the provision of information and risk assessment of contained use of the biologicals with the Clinical trial Centers and keep track of the various submissions in the relevant regions;
• For the Medicinal Products containing GMOs, lead the ERA for both the CTs considered deliberate release and contained use application as well as for the MAA;
• Coordinate the scientific writing of the ERAs, working with expert co-authors, compiling all the relevant information for the ERA and lead review rounds using country specific templates;
• Monitor the relevant legislation and inform internal stakeholders of significant changes.
• Act as SME and define and drive the implementation of the appropriate biological containment and biosafety measures for the use of biologicals in clinical studies, in MAAs and for post-licensing obligations;
• Partner with internal and external in-country regulatory and scientific teams, site biosafety officers and occupational toxicology experts to provide product/non-clinical biological safety subject matter expertise to the global clinical trial programs and/or relevant Market Authorization Applications for biologicals;
• Partner with Global Biosafety SME to develop a strong Biosafety network and standardized biosafety practices for the enterprise;
• Participate in the Global Biosafety Council setting strategic direction for the J&J EHS&S biosafety program.
• Make sure the necessary ERA data is derived/collected;
• Drive the institutionalization of “ERA thinking” and data collection in the development and clinical trial processes, by the development of relevant processes (SOPs and RACIs);
• Develop and lead the Centre of Excellence for ERA applications of medicinal products;
• Monitor and communicate the performance of the ERA program to key stakeholders;
• Evaluate and implement relevant ERA program requirements for products under licensing and acquisitions;
• Build the relevant network and invest in required competences anticipating to future ERA needs.
Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Janssen Pharmaceutica N.V. (7555)