Associate Director, Clinical Study Lead - Immuno-oncology job in London, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM)

Location: United Kingdom

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Proclinical Staffing are proud to be representing a trail blazing biotech in the EU who are looking for an Associate Director, Clinical Trials/ Clinical Study Lead to join their immunology/ cell therapy team based remotely either in the UK or Germany. Being a medium sized company with over 3000 employees globally, our client is looking for an established clinical operations professional with 6-8 years' experience in running global oncology studies (ideally within immuno-oncology/ CAR T-cell therapy) who has a proven track record within the field and can lead teams operationally. Someone coming from a Pharma/ Biotech background will be a strong fit for this position as you'll be involved with the oversight of CROs/ Vendors in this outsourced model, but CRO candidates can also be considered.

You'll oversee and manage their early to late-stage development programs within the immunology group whilst having oversight of the other clinical operations team members based in the EU. It's essential for candidates to have operated globally previously so you can lead the team (non-directly) effectively in this international environment. You are accountable for the continuous adaptation of internal departmental processes to the rapidly growing organisations within the company.

Responsibilities

Leads 1 or more complex/large-scale clinical trial/s in either early or late-stage clinical development within a program (exhibited experience).
Lead communications, issue escalations, and helping the teams within the program to further develop.
May have more junior trial managers reporting. Global study management experience is needed.
Manages the Clinical Research Organisation (CRO) and vendor(s) as it relates to clinical program level deliverables.
Manages clinical study timelines for the program(s).
Ensures inspection readiness throughout the clinical program lifecycle.

Qualifications
Education

A Bachelor's degree in the life sciences or a university degree in a related field with experience in the health industry. Advanced degree preferred. PMP or equivalent certification desirable. Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) to perform clinical research projects. Has been involved with addressing regulatory inspections or internal process audits. Involved in drafting/reviewing responses to Health Authority and Ethics Committee questions.

Experience