Senior Pre-clinical Safety Leader - Romainville, FR
Pleased to meet you, we are Galapagos, a dynamic fast growing biotech company with offices in Europe, in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and in the US (Boston).
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists, we need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
For our site in ROMAINVILLE, France we are looking for a Pre-Clinical Safety Leader
Scope of the job
As Associate Director you will be in charge of the strategic and operational Safety support to the Development as well as the contribution to the transition of new drug candidates from Discovery to Development, then from Development to clinical.
- Represent Galapagos’ Pre-Clinical Department (PCD) in meetings with Authorities, Biotechnology and Pharmaceutical partners, associations, congresses, etc and potentially adapt the way of working according to the Alliance contracts.
- Represent the PCD Department in Project Team meetings (PTM) by proposing testing strategies, building up the safety assessment approach in concert with the Project Team (PT), providing an update on the progress of the PCD programme, drawing the attention of the PT on any points of concern that may have appeared during the progress of the PCD programme, and presenting the options proposed by the PCD Department to resolve issues and/or to clarify points of concern.
- Represent the PCD Department in the MRC (Management Review Committee) meetings.
- Involve other Safety and/or ADME Leaders in order to have sound strategies and accurate updates on the PCD programme (scientific content, timelines and expenditures), to flag any issue/point of concern raised along the PCD programme and to identify different options to address them, with respect to regulatory requirements as well as PT objectives and timelines
- Liaise with other Safety and ADME Leaders and/or with the Head of PCD (if any major outcomes) after the PTM, in order to share feedback from the PT, to highlight on the main outcomes of the meeting and to discuss any issues raised by the PT.
- Contribute to the preparation and review of all regulatory documents (Investigator's Brochure (IB), Investigational New Drug (IND), replies to Regulatory Agency (RA), Development Safety Update Report (DSUR), Clinical Trial Authorizations (CTA), e) with the support of the Safety and ADME Leaders.
- Sign and/or approve non-regulatory and regulatory documents on behalf of the PCD Department.
- Provide sound strategies and accurate updates on the Safety studies, for instance by flagging any issue/point of concern raised during course of studies and identifying different options to address them, with respect of regulatory requirements as well of Project Team (PT) objectives and timelines.
- Outsource, design, initiate, analyse results and monitor the progress of all Safety Pharmacology, genotoxicology and (eco)toxicology studies required for the safety assessment of new drug candidate. This should be done in agreement with the relevant guidelines (e.g. Good Laboratory Practices (GLP) and International Conference on Harmonisation (ICH), European Medicines Agency (EMA), Food and Drug Administration (FDA), Pharmaceuticals and Medical Devices Agency (PMDA)) strategic decisions, Development plan (eg. Timelines, costs) of the project.
- Make sure that the starting materials, intermediates and/or impurities (as required) of the manufacturing process of the drug candidate are provided to the laboratories on time, in collaboration with the Drug Substance (DS) Leader of the Chemistry manufacture and Control (CMC) project team.
- Outsource, design, initiate and monitor the progress of Analytical method validation and Formulation homogeneity/stability studies for the formulations selected for the in vitro and/or in vivo Safety Pharmacology and Toxicology studies.
Prepare and/or present data summaries to be presented at Project Team and Management Review Committee (MRC) meetings in order to update all stakeholders
- and management on the progress and issues (and options forward) of the PCD plan.
- Regularly and timely update the Enterprise Project Portfolio Management (EPPM) database (including timelines, expenditures)
- In collaboration with the DS Leader of the CMC project team, ensure the in silico assessment of mutagenic potential of impurities, intermediates, reagents and degradants of the Active Pharmaceutical Ingredient (API) manufacturing process (according to ICH M7), providing he/she is trained for doing so.
- Contribute to the preparation and review of all regulatory documents with the support of the Pre-Clinical Development (PCD) Leader.
- In collaboration with the DS Leader of the CMC project team, provide the required Safety information to the vendors in charge of the preparation and update of the Material Safety Data Sheet (MSDS) for the new drug candidate (and impurities, metabolites and starting materials, as required).
- On CMC request, prepare relevant safety statements to meet occupational safety needs/obligations at the external CMC vendors.
- Adhere to existing Policies and Procedures and ensure timely completion of relevant training.
- Perform scientific assessment of new and existing vendors.
- Have coaching responsibilities of less experienced (or new) members of the PCD Department as well as support regarding the establishment, maintenance and development of the PCD and more generally Development related-processes.
Who you are?
- Master or PhD in Life Science
- 15+ years industrial experience in toxicology and safety pharmacology
- Proficient use of Microsoft Office
- Excellent command of English
What’s in it for you ?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!