Senior Consultant, Non-Clinical Development
in Breda, The Netherlands.
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and Europe-wide representation.
“Our vision is to deliver results of the highest quality to our global clients on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.”
We are currently looking for a Consultant Non-Clinical Development with hands-on experience to join our Non-Clinical Development Team based in Breda, The Netherlands.
Reporting to the Director Non-Clinical Development, the successful candidate will be responsible for providing expertise regarding the design, execution and coordination of the Non-Clinical elements of a project in a timely manner with high quality awareness.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
- Responsible for the non-clinical activities within a study or project. This may include responsibility for the non-clinical toxicokinetics analysis (including design, execution, reporting and interpretation) as well as responsibility for execution of non-clinical studies (including bioanalytical studies) to support the next phases in clinical development
- Provide scientific non-clinical input to the development strategy
- Ensure that all non-clinical activities are performed according to the applicable guidelines and relevant SOPs and manuals or according to the Sponsor’s requirements;
- Responsible for the scientific soundness of the non-clinical work, including interpretation of study results
- Provide scientific and technical input into the design and reporting of non-clinical and/or toxicokinetic studies
- Monitor non-clinical pharmacological, toxicological, ADME, pharmacokinetic/toxicokinetic studies
- Write, contribute to or review the non-clinical plans, protocols and reports and communicate results with the Sponsor; this may involve non-clinical development plans, non-clinical pharmacological or toxicological studies, non-clinical pharmacokinetic/toxicokinetic studies, and Absorption, Distribution, Metabolism, Excretion (ADME) studies
- Prepare result summaries that would be used for decision-making purposes and presentations
- Responsible for providing relevant inputs into various sections of regulatory documents, such as IB, IMPD, IND, BLA, CTD etc.
- Contribute to Due Diligences and GAP analyses of non-clinical development of candidate drugs
- Contribute to regulatory advice and client representation in communications and meetings with regulatory agencies
- Participate in multidisciplinary Drug Development teams at Venn Life Sciences and at clients
- Support the project leader for non-clinical or drug development projects & act as a Project Manager to ensure that projects are executed within agreed timelines and budget
- Contribute to the success of the project through the successful delivery of non-clinical elements in line with agreed timelines and budget
- Strengthen the working relationships with scientific and business partners
Engage internal and/or external experts (parties) to manage client’s expectations and to address drug development related matters
- Maintain and build a professional network with pharma and biotech companies
- Stay up to date with current trends, knowledge, and developments in area of expertise and proactively identify opportunities to update and increase knowledge and share with others (internally & externally via training, symposia, articles, etc.)
- Actively contribute to the business development e.g. identifying business opportunities, playing a core role in Requests for Proposals preparations, client meetings etc.
- Guide and coach the professionals in the non-clinical department, especially associate consultant non-clinical development but also other professionals, when the circumstances require
- Build recognized expertise at least one in specialty area (e.g. oncology, juvenile, toxicology) that is relevant for drug development
- Ensure high levels of customer satisfaction by focusing on efficiency and results and exceeding customer expectations on assigned work activities
- Acquire and maintain non-clinical development knowledge/expertise for a client or for the business of Venn Life Sciences
- Act according to the quality standard of Venn Life Sciences and/or of client
- Completion of additional tasks not specified herein as required by management to ensure successful/smooth business operations.
Qualifications & Experience
- MSc. or higher-level qualification
- 5+ years’ experience in non-clinical development
- Good experience of non-clinical development and knowledge of regulatory requirements
- Knowledge of integrated drug development process (incl. CMC, Non-Clinical and sClinical Development
- Experience in project management
- Demonstrated, active network with pharmaceutical /biotech companies and key opinion leaders.
How to apply: Please forward your CV (in English) by email to Liane Brown-Feaheny at firstname.lastname@example.org
PLEASE NOTE THAT DUE TO THE HIGH VOLUME OF APPLICATIONS WHICH WE RECEIVE WE WILL ONLY BE ABLE TO REPLY TO CANDIDATES WHOM WE ARE INVITING FOR INTERVIEW.
We do not require the services of agencies for this role.