Associate Director - Clinical Programme Management

We are currently looking for a Associate Director to support Clinical Programme Management within a growing biotechnology firm based in Greater London.

The Associate Director - Clinical Programme Management plays a key role in supporting the planning and execution of programmes per development plan, from initiation through to closeout. You will ensure that all programme management and deliverables are completed on time and within budget and in accordance with SOPs, policies and practices. The role will highlight any risks, slippages and obstacles with plans to mitigate any issues.


KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Associate Director - Clinical Programme Management will be varied however the key duties and responsibilities are as follows:

1. Provide expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study reports, and lead the delivery of study documents. With oversight form the Director, lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions

2. Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalates issues to stakeholders as appropriate

3. Provide input to forecasting and management of study/program delivery costs, resources and timelines. Contribute to the clinical and business project planning of MeiraGTx Gene therapy programmes

4. You will manage a team of direct reports, as well as mentoring and supporting the development of individuals within the organisation.

5.Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators. Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Associate Director - Clinical Programme Management we are looking to identify the following on your profile and past history:

1. Degree or PhD in a relevant biological sciences focussed discipline. You will also be expected to have project management qualifications. In addition, you will be expected to demonstrate significant experience working within drug development in a variety of roles.

2. Significant experience of working in a translational clinical research environment, especially strong project management experience within the context of Clinical Drug Development, and running projects in the gene therapy or advanced therapies arena. You will be expected to demonstrate expert knowledge in ICH-GCP principles.

3. You should demonstrate strong interpersonal skills to influence; communicate and manage change. Proven ability in problem solving and issues management that is solution focused.

Key Words: Associate Director | Clinical Trials | Project Management | Programme Management | ICH-GCP

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.