Translational Medicine, Senior Project Lead
- Experience Level
TRANSLATIONAL MEDICINE, SENIOR PROJECT LEAD
As part of their Translational Medicine team, my client requires a highly skilled translational scientist with deep immuno-oncology or immunology knowledge to take a leading role in progressing their compounds through to clinical-stage.
You will work closely with other translational scientists to support the discovery of biomarkers for pharmacodynamic analysis and patient selection on multiple clinical trials, as well as to define the clinical strategy. In particular, the selected candidate will play a key role in directing and contributing to the development and outsourcing of clinically applicable biomarker assays and the analysis and reporting of the data.
- Leading the development and implementation of biomarker strategies on multiple clinical trials in close interaction with the members of the project team.
- Overseeing translational scientific activities, internally and externally in collaboration with academic partners, to build a scientific rationale to select indications and/or combinations to support the clinical strategy of the project.
- Actively contributing to and supervising the selection, development, qualification/validation of clinically applicable biomarker assays including pharmacodynamic, predictive, prognostic, and safety biomarkers internally and/or in external analytical laboratories.
- Ensuring the implementation of those assays in clinical trials. This includes the writing/reviewing of dedicated sections of clinical documents and other material needed, and requires a close interaction with the Clinical teams and external service providers.
- Overseeing pharmacodynamic and patient selection biomarker testing and complex data analysis across several functional areas.
- Mentoring the experimental work of Scientist(s), Clinical Biomarker Manager (s), and/or Research Assistant(s)
- PhD, MD/PhD in Cancer Biology, Immunology, Cell, or Molecular Biology with a minimum of 10 years of relevant post-doctoral research experience in analyzing human samples and/or monitoring analysis of biological markers during clinical trials. Must have expertise in immuno-oncology or immunology and people management. Previous experience in biotech/pharma industry is clearly a plus.
- Experience with the discovery, characterization, clinical application of biomarkers using flow cytometry, proteomics, molecular biology or immunohistochemistry of human tissue specimens.
- Experience in qualification/validation, development, and outsourcing of clinically applicable pharmacodynamic biomarker assays.
- Experience in implementing bio-assays in clinical studies and good knowledge of GCP/GCLP guidelines and current global regulations
Belgium with flex to work from home
- If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Sam Chapple on +44 (0) 203 868 8607 or e-mail on email@example.com
- If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.