Senior Medical Director

Kelaca; Greater London; On-site; GBP 120,000 - 180,000; Full time

Job summary

Kelaca is seeking a Head of Regulatory & Clinical Safety (Medically Qualified) in London. This senior leadership role focuses on guiding regulatory strategy for early development programs across biotech and pharma sponsors.

You will lead regulatory risk assessment, liaison with authorities, and drive safety integration with the clinical development plan. The role requires medical training with GMC registration and track record in regulatory science, including assessor work for regulators.

Qualifications

• Medical degree and GMC registration.
• Assessor experience at the MHRA or an equivalent agency.
• Solid grasp of early phase trial design and regulatory requirements.
• Experience managing people.
• Deep pharmacovigilance systems experience isn’t required; there’s an established safety team.

Responsibilities

• 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.

Skills

Regulatory leadership

People management

Regulatory strategy

Pharmacovigilance knowledge

Education

Medical degree

GMC registration

Job description

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.