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 sponsors 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 CMC Consultant to join our CMC Team in our office in Breda, Netherlands. Reporting to the Director CMC, the successful candidate will be responsible for providing expertise and guidance on the design, execution and coordination of the CMC elements of projects. The role holder will manage all CMC activities, including responsibility for CMC activities outsourced to CMO’s and CRO’s.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
- Provide scientific CMC input to the development strategy
- Ensure that all CMC 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 CMC work, including interpretation of study results
- Provide scientific and technical input into the design and reporting of CMC studies
- Write, contribute to or review the CMC plans, protocols and reports and communicate results with the Sponsor
- Prepare result summaries that would be used for decision-making purposes and presentations
- Write or review various sections of regulatory documents, such as IB, IMPD, IND, BLA, CTD etc
- Contribute to/perform Due Diligence and GAP analyses of CMC development of candidate drugs and deliver advise how to reach critical CMC development milestones
- Provide regulatory advice and act as client representative in communications and meetings with regulatory agencies
- Participate in multidisciplinary Drug Development teams at Venn Life Sciences and at clients
- Contribute to the success of the project through the successful delivery of CMC elements in line with agreed timelines and budget
- Engage internal and/or external experts (parties) to manage client’s expectations and to address drug development related matters
- Stay up to date with current trends, knowledge, and developments in CMC and proactively identify opportunities to update and increase knowledge and share with others (internally & externally via training, symposia, articles, etc.)
- Proactively participate in business development with commitment to identifying business opportunities with current and new clients as well as manage Requests for Proposals to acquire contracts with existing and new clients
- Guide, coach, supervise and train professionals in the company.
Qualifications & Experience:
- or higher-level qualification
- Minimum of 5-10 years’ experience in CMC activities including submissions to regulatory agencies, interaction with regulatory authorities and CMC module development and review experience
- Good knowledge of integrated drug development process (incl. CMC, Non-Clinical, Clinical development)
- Experience in Project Management.
- Science driven mindset with the ability to communicate to clients and identify the needs of the clients
- Ability to find effective solutions to deal with complex matters (e.g. resolving independently or with support of other
- Excellent influencing, organisational and leadership skills with demonstrated ability to listen, lead and motivate particularly across a multicultural organisation
- Ability to multi-task, with skill in establishing priorities, managing workload and meeting strict deadlines
- Team worker, who can also work independently, with strong interpersonal skills, ability to communicate effectively and form positive relationships at all levels in and outside the company
- Excellent networking skills to connect to pharmaceutical / biotech companies
- Proficiency in PC skills (e.g. SharePoint, Word, Excel, PowerPoint and Outlook)
- Flexibility to travel and work at different locations
- Excellent written and verbal communication skills including excellent command of English.
How to apply: Please forward your CV (in English) by email to Liane Brown-Feaheny, email@example.com
We do not require the services of agencies for this role.