George Higginson is pleased to be offering an incredibly rare opportunity to be exclusively partnered with the market leading, commercial-stage biopharmaceutical company, in search for an experienced Senior Clinical Scientist.
The client currently has one FDA approved product on the market within B-cell lymphoma. In addition to this, x4 other products currently in Phase 3 trials, in their pipeline to date.
Since opening their U.S. office in Boston, they have doubled in size to supporting rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.
- Responsible for providing medical / scientific input and expertise to individual clinical trial(s) within a global development program of a disease area
- Represent Clinical Development in Clinical Trial Teams (CTT), participate and contribute in clinical sub teams and other committees needing medical support
- For the assigned clinical trial(s) within a program, as a member of the CTT, provide medical and scientific input to: all activities related to planning, execution and reporting of clinical trials; development of trial related documents (e. g. protocols, case report forms, data analysis plan, reports, publications); development of presentation material for trial-related advisory boards, investigator meetings, protocol training, etc.
- Ongoing review of clinical trial data, final analysis and interpretation, in collaboration with the Safety Leader and appropriate CTT members.
- Build relationships among the clinical / scientific community and with external experts
- Maintain sponsor oversight on data quality and product safety in clinical trials via regular medical monitoring activities in collaboration with the Safety Leader and appropriate Clinical Trial Team members. Perform hands on medical data review, as needed.
- Support regulatory authority interactions, information requests etc (e.g. FDA and EMA) as needed
- Based on individual expertise, perform evaluations of potential drug targets and drug candidates for future clinical development
- Ideally PharmD, PhD, or MD in health sciences / translational research with substantial experience in clinical development and clinical research with 3+ years of experience
- Experience in early and/or late drug development (Phase 1-3)
- Ability to critically evaluate drug targets or drug candidates based on published data or preclinical research findings and to translate these findings into clinical hypothesis testing
- Excellent medical writing and presentation skills
Preferred (But Not Required):
- Strong background in haemato-oncology, oncology or immuno-oncology preferred
- Ideally 3+ years of relevant professional experience, ideally in the pharmaceutical or biotechnology industry
- Prior experience in regulatory authority interactions / submissions preferred but not a must
Health & Safety
Full vaccination against COVID 19 is a requirement for this position.
How To Apply
AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.
Tel: +44 (0) 203 778 0909