Head of Regulatory & Clinical Safety (Medically Qualified)
I’m working on a confidential leadership hire for an established early phase CRO in London. Their work centres on first-in-human and early clinical studies for biotech and pharma sponsors, across a broad range of modalities.
They’d like to speak with physicians who have worked as medical or clinical assessors at the MHRA (or another European regulator) and want to apply that experience on the development side.
What you’ll do
- Advise sponsors on the regulatory route into the clinic and through early development
- Be the lead contact for regulators on behalf of the business
- Manage a team covering regulatory, scientific writing and drug safety
- Join sponsor and new business conversations as the senior regulatory voice
What you need
- Medical degree and GMC registration
- Assessor experience at the MHRA or an equivalent agency
- A solid grasp of early phase trial design and regulatory requirements
- Experience managing people
- Deep pharmacovigilance systems experience isn’t required, as there’s an established safety team in place
Why consider it
A senior role where regulatory judgement shapes programmes from the very start, plus a significant step up in package for anyone moving across from the regulator.
Conversations are fully confidential and the client is shared after an initial call.
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Senior Medical Director in London employer: Kelaca
Kelaca is an exceptional employer that fosters a dynamic and innovative work culture in the heart of London. With a strong emphasis on employee growth, you will have the opportunity to engage directly with clients from the outset, translating AI capabilities into impactful business solutions. The collaborative environment encourages independent thinking and offers unique advantages such as access to cutting-edge technology and a commitment to driving meaningful outcomes.
