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 Consultant Clinical Pharmacokinetics to join Clinical Development Team based in our office in Breda, Netherlands. Reporting to the Group Leader Clinical Consultancy, the successful candidate will be responsible for providing expertise regarding the design, initiation and coordination of the Clinical Pharmacokinetic elements of the study or part 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.
Responsibilities and Accountabilities:
• Provide Clinical Pharmacokinetic consultancy and service activities to clients, e.g.:
o Supervise the pharmacokinetic non-compartmental analysis to make sure that it is performed according to the ICH-GCP Guidelines and relevant SOPs and manuals or according to the Sponsor’s requirements
o Responsible for the scientific soundness of the pharmacokinetic results
o Write or review the pharmacokinetic report and communicate/discuss results with the Sponsor
o Provide scientific and technical input into the design and reporting of clinical pharmacology studies and development strategy
o Responsible for providing relevant inputs into various sections of regulatory documents, such as IB, IMPD and CTD, with support from consultant, if needed
o Manage exploratory pharmacokinetic analyses and prepare result summaries that would be used for decision-making purposes and presentations
o Contribute to the success of the project through the delivery of Pharmacokinetic elements in line with agreed timelines and budget
• Act as Project Manager and client point of contact for Clinical Pharmacology studies, leading/directing data analysts, medical writers and other project members as required and ensuring that projects are executed within agreed timelines and budget
• Support business development effort by identifying business opportunities with current and new clients, playing a core or supporting role in Request for Proposals preparations, client meeting etc.
Qualifications & Experience
• Bachelors or higher qualification in life sciences or pharmaceutical science
• At least 2-3 years relevant work experience within a pharmaceutical company. Or 3-5 years equivalent work experience e.g. CRO, regulatory activities in government agency, Clinical PK/PD analysts
• Working knowledge of Pharmacokinetics and Clinical Pharmacology discipline and its methods and approaches
• Up-to-date knowledge of the latest EMEA/FDA Biopharmaceutics, Clinical Pharmacology, relevant pharmacokinetic-related guidance, and other relevant regulations
• Project Management experience
• Ability to find effective solutions to deal with complex matters (e.g. resolving independently or with support of others/seniors)
• Ability to be flexible and to adapt and work effectively with a variety of clients, situations or individuals
• Ability to multi-task, with skill in establishing priorities, managing workload and meeting strict deadlines
• Ability to communicate to clients and identify the needs of the clients
• Demonstrate good judgement and decision-making capability
• Good influencing and collaboration skills with ability to listen, particularly across a multicultural organisation
• Team worker with ability to communicate effectively and form positive relationships in and outside the company
Please forward your CV (in English) by email to Liane Brown-Feaheny at email@example.com