Clinical Research Scientist

Alchemab Therapeutics Ltd; Cambridgeshire and Peterborough; On-site; GBP 40,000 - 60,000; Full time

Job summary

A biotechnology company in the UK is seeking a Clinical Research Scientist to lead clinical strategy and author key documents. The ideal candidate will have a PhD or equivalent, extensive experience in early clinical development, and skills in team collaboration. Responsibilities include developing clinical designs, drafting protocols, and ensuring compliance with regulatory guidelines. This role offers a dynamic environment in the biotech sphere.

Qualifications

• Advanced scientific training or relevant industry experience.
• Solid track record in early clinical development.
• Familiarity with GCP and UK/EU/US regulatory pathways.
• Experience with medical data review and presentations.
• Exceptional communication and interpersonal skills.

Responsibilities

• Develop pragmatic clinical designs for programs.
• Research and define clinically meaningful endpoints.
• Draft clinical protocols and key study documents.
• Contribute to Clinical Trial Authorisation and IND content.
• Stay updated on innovative clinical trial strategies.

Skills

Clinical development track record

Clinical protocol authorship

Strong communication skills

Ability to collaborate effectively

Understanding of market dynamics

Education

PhD, PharmD, MD or MSc

Job description

Overview

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 Alchemab's 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 Development: Participate actively to the gap assessment to any "bound-for-clinic" program and translate findings into pragmatic clinical designs.
• Strategy Development: Research and define clinically meaningful endpoints (including exploratory/digital/biomarker endpoints) and outline timing, feasibility and risk trade-offs.
• Strategy Development: 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.
• Strategy Development: Partner with Commercial team representatives to lead the drafting of the target product profile.
• Strategy Implementation: Draft the Clinical Concept Sheet for usage in Contract research Organisation (CRO) selection, KOL conversations and other elements.
• Strategy Implementation: Author/review clinical protocols, amendments and key study tools.
• Strategy Implementation: Contribute to Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) Application enabling content (clinical sections of Investigators Brochure (IB).
• Strategy Implementation: 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.
• Keeping Abreast of Innovations: Staying up-to-date on innovative approaches to generating rapid PoC data.
• Keeping Abreast of Innovations: Understanding the competitive landscape for key therapeutic areas.
• Cross Functional Teamwork: Core member of the Development team for select programs.
• Cross Functional Teamwork: Member of the Clinical/Regulatory Sub-Team (CRST) for select programs, with potential to chair.
• Cross Functional Teamwork: Member of RFP/vendor selection groups and internal/external Clinical Trial Teams;
• Cross Functional Teamwork: Act as a delegate, where appropriate, for the CMO/Medical lead.

Essential Qualifications

• 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 [e-mail] if you think you can help in the future.