Interim Director, Clinical Science

Oxford, United Kingdom

CK Group

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Job Description

Functional Expertise: Clinical Operations/Development, Research & Development

CK Group are looking for a Director, Clinical Science to join a well-funded Immunology biotech who are preparing for their lead candidate to start clinical trials.
This will be a hybrid role requiring you to be on-site in Oxford once a week, possibly less if you live further away.
RESPONSIBILITIES:
As Director, Clinical Science you will play a lead role in the design, execution and scientific management of clinical trials for a portfolio of Autoimmune treatments.
Key duties will include:

Leading the development of clinical trial synopses, clinical protocols and other key clinical trial documents.
Leading the development of biomarker strategy and implementation of plans to support early clinical development endpoints.
Development of strong relationships with KOLs and investigational centres in order to facilitate strong scientific engagement with the company's clinical programs.
Contribution to the development and review of regulatory submissions and interaction with Regulatory Authorities.
Oversight of the review of study data in collaboration with biostatisticians and data scientists.

QUALIFICATIONS:
As Director, Clinical Science you will require:

A relevant PhD
Extensive experience of the design and oversight of early phase, small molecule Autoimmune studies.
Experience of working with Atopic Dermatitis or Psoriatic Arthritis will be advantageous
An in-depth knowledge of relevant regulatory requirements and experience of working with Regulatory Authorities.
Excellent communication and interpersonal skills, with the ability to work effectively in multi-disciplinary teams.

BENEFITS:
Competitive day rate.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 155459 in all correspondence.
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