Clinical Research Scientist

Alchemab; Cambridgeshire and Peterborough; On-site; GBP 40,000 - 70,000; Full time

Job summary

A biopharmaceutical company in the UK seeks a Clinical Research Scientist to collaborate on clinical designs and draft key documents for early clinical trials. The ideal candidate will have advanced scientific training, experience in early clinical development, and a strong ability to work with cross-functional teams. Responsibilities include authoring clinical protocols, defining endpoints, and driving KOL discussions. Exceptional communication skills and a solid regulatory understanding are essential for this role. Employment type is full-time.

Qualifications

• Advanced scientific training (PhD, PharmD, MD) or MSc with strong industry experience.
• Solid track record in early clinical development (FIH / Phase 1 / 2).
• Demonstrated authorship of clinical protocols and related study documents.
• Experience with medical data review and study interpretation.
• Strong understanding of biotech product development processes.

Responsibilities

• Participate actively in gap assessments and define clinically meaningful endpoints.
• Draft the Clinical Concept Sheet for CRO selection and review clinical protocols.
• Research and educate on clinical trial strategy and design.

Skills

Laboratory Experience

Machine Learning

Python

AI

Bioinformatics

C / C++

R

Biochemistry

Research Experience

Natural Language Processing

Deep Learning

Molecular Biology

Education

PhD, PharmD, MD or equivalent

MSc with strong industry experience

Job description

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 Development

• Participate 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 Implementation

• Draft 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 areas.

Cross 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 lead.

Essential

• 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.

Key Skills

• Laboratory Experience
• Machine Learning
• Python
• AI
• Bioinformatics
• C / C++
• R
• Biochemistry
• Research Experience
• Natural Language Processing
• Deep Learning
• Molecular Biology

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.

Employment Type : Full‑Time