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Associate Director/Director, Clinical Operations/Clinical Scientist – Neuroscience

Location Cambridge, England, United Kingdom Job ID R-066780 Date posted 11/26/2019

Associate Director/Director, Clinical Operations/Clinical Scientist – Neuroscience

Location(s) – Cambridge (UK)

Salary - Competitive salary and company benefits apply

Are you passionate about joining a company that truly puts patients first? We would love to hear from you if you are keen to hear more about an opportunity in our Neuroscience group.

At AstraZeneca, every one of our employees makes a difference to patient lives every single day. We are building on our strong pipeline and turning ideas into life-changing medicines that benefit patients around the globe.

The new BioPharmaceuticals R&D organisation brings together research and development teams, from discovery through to late-stage development for Neuroscience and Microbial Sciences, Cardiovascular, Renal & Metabolic (CVRM), Respiratory, Inflammatory and Autoimmune (RIA) therapy areas.

Role

You will play a key role in design, initiation, leadership and delivery of clinical studies which will help to drive the clinical development of novel molecules to treat chronic pain and neurodegenerative diseases.

With a strong background as a clinical scientist or in clinical operations, you will lead and coordinate clinical teams and conceive or contribute to clinical strategy and planning. We need you to identify data driven decision points and balance the day-to-day interactions and relationships between the sponsor, delegated vendors and business partners to enable planning, initiation, execution, conduct and reporting of high-quality clinical trials. Delivery of studies will be consistent with project plans and strategic objectives, and in accordance with FDA, CFR, EMA, and ICH GCP regulations

You will oversee regulatory (FDA, Competent Authority) and local IRB and Ethics Committee submissions and interactions and author and review clinical documents and clinical sections of regulatory documents including Investigator Brochures and IMPDs.

You will be accountable for two or three clinical studies simultaneously and will assess, select and contract vendors including CROs and clinical trial sites. We need you to own the development of study synopses, protocols and other key study documents in collaboration with the clinical CRO and project team experts. We expect you to be accountable for subject recruitment and enrolment to achieve timelines and quality and for sponsor oversight of CROs and other vendors including completeness of the eTMF, oversight of investigating sites, adherence to regulations and maintaining performance and quality metrics.

You’ll be part of a team that pulls together to put patients first.

Responsibilities:

Reporting to the Head of Projects, you will have the following duties:

  • Lead the planning, design and authoring of synopses and protocols and ensure implementation is carried out according to GCP, ICH and all AZ quality standards. Working closely with Neuroscience physicians and scientists, develop and design studies to determine the scientific and clinical viability of experimental drugs and interpret trial results, either as the head of a team, or by providing expert input. Present and defend protocols and underlying science at internal governance boards. Review and interpret clinical trial data.
  • Key relationships will be in cross functional project teams where you will represent clinical operations/science. You will have key relationships internally with clinical project teams, and externally with regulatory bodies, KOLs and external service providers.
  • Contribute to the improvement of processes, systems, tools, procedures meaningful to Neuroscience and the wider organisation and including SOP review, development and adherence
  • Matrix/indirect management of cross-functional project teams to deliver clinical phase projects. Not anticipated to have direct line management responsibilities.

Requirements

You will possess extensive industry experience in Clinical operations or drug development, in the neuroscience field, in design and execution of Phase II and III studies.

And you'll be University educated in the Life sciences field, preferably to a PhD level, but this is not essential. Neuroscience training and experience in academia or industry, particularly in chronic pain or neurodegeneration, is desirable.

Other skills needed for the role are:

  • Ability to work independently.
  • Strong computer literacy/proficiency across multiple programs to facilitate daily work load.
  • Strong interpersonal skills
  • Excellent attention to detail
  • Leadership, organisational, project management skills
  • Ability to interact with and influence a broad section of partners at all levels including senior managers both internal and external to AZ.
  • Basic understanding of study/project finance and accounts
  • Ability to network and use multiple resources to find opportunities for growth and development.
  • The flexibility to travel internationally on an ad-hoc basis.

Next Steps – Apply today!

We feel that we are a wonderful place to work, coupled with an industry-leading portfolio of products that make AstraZeneca an employer of choice.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.