Belgium
I am an experienced Drug Development Leader with a demonstrated history of working in project management teams. In addition, I took care of medical writing of regulatory documents and scientific papers. Strong research professional skilled in Preclinical pharmacokinetics, Toxicology, Biomarkers and Good Laboratory Practice (GLP). I supported development projects in gastrointestinal, infectious disease, oncology and CNS. I was early development leader for edurant and sirturo and PCD leader for balversa My career objective is to improve quality of life by developing new drugs or as a partner in healthcare projects. I am strongly science oriented and like to solve complex issues taking into account timelines and budget. My preference is to reach my goals in a team where trust and empowerment are key. I have a broad interest going beyond science such as HR and recruitment, production, regulatory, planning, trainer/coaching, communication and public relations.
The mission of Eden is to improve quality of life by giving assistance in developing new drugs or as a partner in healthcare projects. Eden is strongly science oriented and likes to solve complex issues occurring during the drug development process taking timelines and budget into account. The intention of Eden is to work as consultant/freelance or in collaboration with other consultants and specialist providers to support spin-offs, small pharma companies or government in (early) drug development. In large pharma I can support the end-to-end process. In scope are also chemical industry, schools and universities The values of Eden are Passion, Respect, Integrity and Trust, values which are key in partnerships with our clients I worked in Infectious diseases, gastrointestional diseases, CNS and oncology. My main expertise is oncology I support the following activities: *) Eden supports the design of drug development programs from-end-to-end but with a preference for early development. Design of preclinical (ADME and toxicology) development plans (activities and budget). On request, scientific support at the level of individual studies or trials such as CRO scouting, protocol generation, followup of studies, data interpretation, reporting and if requested presenting *) Building bridges between preclinical ADME/TOX and clinical pharmacology (input in clincal protocols and trial designs and review of studies) *) Writing of regulatory documents in order to submit a CTA or IND and of scientific publications in peer reviewed journals *) Search and apply for grants *) Drug development coaching & mentoring *) Support in due diligence activities *) Interim management - people leader *) A taste of mindfulness in an Industrial setting Eden has a broad interest going beyond ADME/Toxicology such as clinical pharmacology, regulatory, project planning, trainer/mentor/coaching, HR and recruitment, production, external communication