Role Overview
To help us with our mission we have an exciting opportunity for an experienced Head of Biometrics and Medical Writing to join us and lead the Biometrics & Medical Writing functional group to effectively deliver CDD clinical trials to the appropriate regulatory and quality standards in the UK and EU. The Cancer Research UK Centre for Drug Development (CDD) is the world's only charity‑funded drug development organisation. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium‑sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in.
Key Responsibilities
* Lead and manage the Biometrics and Medical Writing teams, ensuring they are engaged, high‑performing and aligned with CDD objectives.
* Work with functional leads to deliver CDD clinical trials on time and within budget, ensuring appropriate resource allocation and efficient processes.
* Ensure all Data Management, Medical Writing and Statistical Sciences activities comply with ICH GCP and all relevant UK/EU regulatory requirements.
* Provide oversight of statistical expertise to support robust trial design, high‑quality datasets and successful onward development.
* Continuously review and improve operational processes to enhance delivery speed, quality and regulatory compliance.
* Act as Data Custodian for CDD, working with Data Privacy teams to ensure full compliance with UK and EU GDPR and data‑privacy legislation.
* Serve as a key liaison with the CRUK Technology team and oversee relevant technology systems including computer system validation (CSV).
* Take accountability for selecting and managing external service providers, ensuring adherence to CRUK, CDD and regulatory requirements.
* Contribute to CDD strategy and leadership, including budget preparation and representing CDD internally and externally.
* Deputise for the Director of Drug Development as required.
Required Qualifications
* Science graduate or PhD (or equivalent relevant experience)
* Extensive experience of clinical trials and drug development within the Pharma/Biotech/CRO industry.
* Extensive experience working with clinical trial data within Data Management, Medical Writing and/or Statistical Sciences, involving the design and delivery of complex processes to GCP standards.
* Proven team management experience (including working within matrix team systems).
* Working knowledge of current legal and regulatory requirements for early clinical trials in the UK and EU, as well as regulations and guidelines for computerised systems.
* Working knowledge of UK and EU GDPR and data privacy legislation.
Desirable Qualifications
* Oncology experience.
* Experience of early phase trials.
Our Organization Values
* Bold: Act with ambition, courage and determination
* Credible: Act with rigour and professionalism
* Human: Act to have a positive impact on people
* Together: Act inclusively and collaboratively
We're looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer.
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