Associate Director, Translational Operations

At AstraZeneca, we win through the science, it is at the heart of our every success. Every decision is rooted in the limitless possibilities of what science can do. We push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and build new value for shareholders. It also sets the context for our employees’ activities and the roles of our teams, partners, and other collaborators. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Role Summary:

As a key member of the Biosamples & Translational Operations team you will drive biosample strategy and implementation at the Therapeutic Area (TA) level, supervising several global clinical trials. You will collaborate cross functionally with many collaborators across Research and Development and, as a result of your expertise and efforts, we will optimize the collection and utilization of our clinical trial samples and data to meet protocol requirements and scientific aspirations.  This ensures that we deliver on our promise to our rare disease patients and support our scientists to follow the science through timely access to all available samples. 

You will be responsible for clinical sample life-cycle management within Alexion and across our labs and third-party vendors for the clinical trials to which you are assigned. To do so, you will partner with colleagues from Translational Sciences, Translational Medicine, Outsourcing Management, Clinical Operations, Data Management, Clinical Development, and the Biobank. This role requires a combination of scientific, strategic, and project management expertise with excellent communication skills and attention to detail. 

You will be responsible for: 

• Supporting strategic discussions about sample collections within your assigned TA 

• Leading the operational implementation of the biosample strategy as described in Translational Science and Experimental Medicine (TSEM) plans to ensure high quality bioanalytical, biomarker, and diagnostic biosample analysis for multiple priority clinical trials 

• Providing input into clinical trial protocols/synopses and informed consent forms to ensure logistical feasibility of clinical sample strategy as well as alignment with all Clinical Sample Plans, ICH/GCP, and local regulations

• Drafting the Sample Lifecycle Plan (SLP) and reviewing clinical trial protocols/synopses, informed consent forms, and other key study documents to ensure alignment with the overall biosample strategy and compliance with ICH/GCP and local regulations

• Ensuring sample chain-of-custody in maintained in a GxP-compliant setting. Logistics planning and coordination with Clinical Operations, clinical sites, external labs, vendors, and couriers to meet timelines needed for sample testing and data transfer according to study landmarks 

• Collaborating closely with Data Management, Clinical Operations, and Translational Sciences and/or Translational Medicine to resolve clinical study sample related data queries to meet study analysis timelines and database locks 

• Serving as contact for Outsourcing Management to initiate vendor contracting

• Engaging with Third Party Lab vendors regarding sample shipping/ receipt and addressing sample related issues 

• Establishing overall lab sample accountability strategy across studies

• Innovating in process development and operational excellence. Tracking lessons learned and applying them across trials and TAs for consistency and continuous improvement activities

• Contributing to central lab training materials & review of laboratory manuals. Input to kit design, sample processing, collection, storage, shipping requirements  

• Preparing and reviewing documents to support virtual or onsite trainings and  meetings  

• Supporting communications and building relationships with key external partners including CROs, vendors and other external collaborators

• Using tracking systems to report progress, metrics, address issues and aim to resolution

• Representing Translational Operations at meetings to ensure deliverables related to clinical trial samples are met

• Supporting Health Authority inspections as needed

• Acting as coach and mentor to less experienced colleagues and supporting overall development of the team and capability

Essential Skills/Experience:

• Minimum of 8+ years of biopharmaceutical R&D experience in drug development and participation in proj