Clinical Development Manager

We are thrilled to offer an opportunity to become a member of our team at Clinical Unit Cambridge (CUC) as a Clinical Development Manager.

As a Clinical Development Manager, you will be responsible for multiple clinical studies within CUC with end-to-end involvement from protocol development to study execution and final study report. Your focus will be on organizational setup, operational management, and oversight responsibilities.

You will establish strong collaborative relationships with prestigious institutes in and around Cambridge/London area, as well as within the experimental medicine network to set up collaborative experimental medicine projects.

In this role you will

• Lead operational excellence in study conduct, ensuring successful execution of study set-up, study procedures and key negotiations with vendors and strategic partners.
• Manage, maintain and track the portfolio of studies placed at the CUC as proposed, planned, initiated and completed.
• Lead activities around patient involvement in clinical research in line with GSK’s “Focus on the Patient” initiatives and processes
• Execute, supervise, or coordinate the required applications for approvals (IRAS, adoption to NIHR portfolio, ethics, NHS R&D, ARSAC etc) of designated studies.
• If required by Global Clinical Delivery (GCD), to act as a central team Study Delivery Lead (SDL) for either CUC or non-CUC studies.
• Ensure compliance with ICH/GCP, regulatory and ethical guidelines, and GSK/CUC SOPs, for all products and services delivered for designated studies

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science or equivalent, or professional qualification in a life science field
• Broad understanding of the pharmaceutical industry and the clinical development process
• Some practical knowledge of study delivery, associated processes and key documents

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
• In depth experience of study delivery within a Clinical Pharmacology Unit
• Thorough knowledge of ICH GCP, GMP and GxP requirements, regulatory and ethical requirements, SOPs and policies
• A proven track record of developing high quality experimental medicine clinical protocols and other study documents
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrix environment
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams

Closing Date for Applications – 24th July (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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