A clinical stage infectious disease biotech has been given a new round of funding for a host of early phase I and II products.
One of the most important ingredients needed in Clinical Operations is an exciting platform of products to work with that will help save patients lives.
If this is here, then talented and motivated people will join, from here more trials are opened and more funding received. Leading to breakthrough drugs such as Keytruda, Humira, Opdivo, CAR-T.
A highly specialised infectious disease technology platform is being created with the help of three other major organisations and charities. Tipped to be revolutionary in approach and hopefully life changing to those people who need it most.
If you are working in Clinical Research or Clinical Project or Clinical Development and would like to learn more about this biotech and how you can join then please continue reading - I would be keen to connect with you.
Role responsibility;
The Clinical Development / Operation Project Leader Role:
- Manage a team of 5 Clinical Project Managers in the infectious disease development programme.
- Work within the personalised Medicine and Cell therapy clinical trials, either first in man studies or phase II drug efficacy studies
- Communicate between the internal biotech stakeholders and the CRO / Regulatory external stakeholders.
- The CPM / Clinical Development Project manager will also supervise CRO's and other external service providers' performance with respect to implemented processes, quality, timelines, milestones and costs
- Work closely with the internal clinical teams and ensure correct budgeting plans and future strategy of the product
- A Clinical Development Project Manager will also prepare data, be responsible for the trail documentation and support the creation of presentations, trial documents and publications
- Coordination and monitoring of project progress especially focusing on clinical projects at early and late development stages, taking over responsibility for the respective projects- coordination of the interfaces between the operative clinical team and other relevant functions such as strategic clinical development, biomarker, CMC, preclinical
- Visit clinical trial investigators and provide them with their needs, such as Case Report Forms (CRF), drug samples, and stipends etc. (not often)
- Support the Clinical Data Manager and Clinical Research Associates and offer coaching when needed
The ideal Clinical Development Manager / Clinical Development Project Lead is;
- BSc Educated (or above) in Life Sciences (Essential)
- Previous work in Clinical Operations or Development (Essential)
- Previous line management experience (Not essential but highly desirable)
- Previous Oncology or Haematology experience (Not essential but highly desirable)
- Previous Biotech / Pharma experience (Not essential)
- Strong communication style
- Work from home or in Frankfurt office (Must be able to travel from time to time).
- Fluency in English
What's in it for those working in Clinical Research Development Operations?
- Salary ranges depend on experience (competitive ranges)
- Home office / In-house Flexibility
- High exposure to senior management team.
- One of the top 10 European Oncology biotechs.
- Working with CART and Personalised Medicine.
- Continued career support and development.
- Team events and support network.
- Working with highly passionate and motivated team.
- Hot tea and coffee & fresh fruit.
This client has multiple positions open including CRA position, Clinical Development Managers and Clinical Project and Senior Project Manager positions.
If you are not sure - feel free to apply anyway - if there is a fit then we can set up a time to speak. ALL APPLICATION ARE 100% CONFIDENTIAL and shared with no-one without your permission.
You can apply here, send me an email () or call (0044-203-758-8923).
Look forward to seeing your hopeful application.
Charles Spence, European Biotech Recruitment specialist.
Keywords
Clinical Development Project Manager - Clinical Development Project Lead - Project Leader
Infectious Disease
Clinical Research Associate ( CRA )
Clinical Project Manager ( CPM ) - Clinical Study Manager ( CSM ) - Clinical Trial Manager ( CTM )
Clinical Development Project Manager
Senior Development Project Manager
Working from home - Home Office - Flexible Working
German - Germany - English