Clinical Research Scientist

5 days ago

Cambridge, United Kingdom Alchemab Full time

The Role The Clinical Research Scientist will report to the VP Development Strategy & Clinical Operations within the Development team and will collaborate on the development of clinical designs and draft key clinical documents including the protocol to take Alchemabs first programmes into the clinic. The role will partner with cross-functional teams to share early clinical strategy design fit-for-purpose phase I/II studies. The Clinical Research Scientist will author clinical documents and drive scientific data reviews during conduct to accelerate proof of concept decisions (PoC).Responsibilities Strategy DevelopmentParticipate actively to the gap assessment to any bound-for-clinic program and translate findings into pragmatic clinical designs.Research and define clinically meaningful endpoints (including exploratory/digital/biomarker endpoints) and outline timing feasibility and risk trade-offs.Work with the Development team (development Translational and Biomarker Leads) and the Clinical/Regulatory Sub Team (CRST) to develop a recommendation for the PoC strategy.Partner with Commercial team representatives to lead the drafting of the target product profile.Strategy ImplementationDraft the Clinical Concept Sheet for usage in Contract research Organisation (CRO) selection KOL conversations and other elements.Author/review clinical protocols amendments and key study tools.Contribute to Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) Application enabling content (clinical sections of Investigators Brochure (IB).Drive the formation of program-specific KOL boards to review the protocol and strategy choices.Keeping abreast of innovations:Researching and educating the wider Alchemab team on approaches to clinical trial strategy and design.Staying up-to-date on innovative approaches to generating rapid POC data.Understanding the competitive landscape for key therapeutic areasCross Functional teamwork:Core member of the Development team for select programs.Member of the Clinical/Regulatory Sub-Team (CRST) for select programs with potential to chair.Member of RFP/vendor selection groups and internal/external Clinical Trial Teams;Act as a delegate where appropriate for the CMO/Medical leadEssential Advanced scientific training (PhD PharmD MD or equivalent) or MSc with strong industry experience.Solid track record in early clinical development (FIH/Phase 1/2) within biotech pharma or CRO.Demonstrated authorship of clinical protocols and related study documents; familiarity with GCP and UK/EU/US regulatory pathways (CTA/IND).Experience with medical data review and study interpretation; comfortable building slides and presenting to senior/internal and external audiences.Strong understanding of biotech product development processes regulatory requirements and market dynamics.Exceptional communication and interpersonal skills with the ability to collaborate effectively with internal and external stakeholders.NOTE: This job description is not intended to be all inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organisation.Note to recruitment agencies: we are not looking for assistance at this stage so please contact the HR department only at if you think you can help in the future.Required Experience:Senior IC Key Skills Laboratory Experience,Machine Learning,Python,AI,Bioinformatics,C/C++,R,Biochemistry,Research Experience,Natural Language Processing,Deep Learning,Molecular Biology Employment Type : Full-Time Experience: years Vacancy: 1

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