Our Cambridge based client is seeking an exceptional group leader for one of their lead programs. In this role you will be vital in progressing/leading translational development for late stage clinical programs through to potential NDA filing. You will bring a wealth of knowledge to the table in developing both pre-clinical and clinical assets.
Oncology experience is a must have.
Lead a group of Ph.D. and non-Ph.D. scientists to develop and implement strategies for clinical biomarker testing, indication expansion, life cycle management, patient stratification, combination therapy, mechanism of action studies, and drug candidate differentiation
Represent Translational Science on lead program’s core team, which leads the clinical development and life-cycle management of lead clinical program and lead preclinical sub-team, which include multiple preclinical functions and reports to the core team
Develop clinical biomarker testing strategies for all lead program clinical trials, collaborate with clinical team and clinical assay development team in clinical sample collection and testing, and communicate translational designs and findings with clinical investigators
Author and review the translational sections of regulatory documents as well as scientific/clinical publications, and represent client to present translational findings at scientific congresses and investigator meetings
Manage external collaborations with KOLs and clinical investigators aimed at gaining a deeper understanding of MOA and the development of patient stratification biomarkers
Assemble and manage a high-performance translational team to ensure successful preclinical and clinical development
Ph.D. in biochemistry, cell biology, pharmacology, medical science, or related fields is required
At least eight years of drug development experience in industry is required
At least five years of management experience in industry is required, with adequate experience in managing PhD level scientists
Experience in leading biomarker testing in clinical trials for oncology drug development is required
Experience with small molecule drug development is required
Outstanding track record of scientific achievement and excellent soft skills are required
Deep understanding of epigenetics is preferred
NDA experience preferred