CRO Senior Manager Translational and Biomarker Development

Are you ready to make a significant impact in the world of rare diseases? As a Biomarker CRO Senior Manager in Alexion R&D’s Translational Sciences group, you will play a crucial role in advancing our mission. You will manage vendor relationships, coordinate translational research-related assays, biomarker method transfers/validation, and ensure CROs successfully implement pre-clinical and clinical sample testing. Expertise in bioassay technology, regulatory guidance on assay validation, sample handling, bioanalysis documentation, and the ability to navigate complex projects will be key to driving our innovative research forward. You will be responsible for holding the CRO accountable for results and deliverables per agreement as captured in communications and SOW proposal.

Accountabilities

• Lead in the identification and selection of the “right” CRO for the “right” bioassays and study objectives to support pre-clinical and clinical bio sample testing. Integrating these services effectively into Alexion’s global operations
• Work closely with and provide support to Alexion Global Strategic Sourcing (GSS) and Legal to ensure clinical trial-supporting contracts are in place and in alignment with study plans and protocols while best serving Alexion’s interests
• Use strong communication skills to assist in technical details of contracts, negotiate timelines with CROs to meet project deadlines. Effectively hold vendors accountable for high-quality data and associated timelines
• Ability and desire to build a collaborative and trustworthy relationship with vendors and their project leads to ensure a strong, stable, and durable working relationship
• Maintain a clear and comprehensive understanding of Alexion procedures related to outsourcing and vendor management
• Participate in the qualification/validation of fit-for-purpose assays at CROs, with an understanding of the timelines and how these activities fit into the larger project framework!
• Ensure that CROs follow GCLP and BMV guidance for regulated sample testing
• Ensure project timelines are met via communication and mitigation of risks, vendor tracking, and ensuring vendor transparency during project execution
• Participate in regular interactions with CROs to facilitate any outsourced activities
• Able to effectively and clearly communicate across departments in a timely fashion, in conjunction with Project Leads
• Call out, when technical or logistical issues necessitate, as appropriate within CRO and/or Alexion management

Essential Skills/Experience

• Ph.D. with 5 years, MS degree with at least 8 years, or BS with a minimum of 10 years’ proven experience in bioanalysis, biomarker support, and/or other relevant pharmaceutical sciences.
• Experience working with bioanalytical/biomarker CROs and ability to facilitate Sponsor-CRO interactions.
• Experience with bioanalytical and biomarker method development and method transfer for LBA and LC-MS/MS platforms and omics experience with the operational execution of biosample analysis in non-clinical and clinical studies
• Knowledge of BMV guidance, GLP, and GCP regulations
• Highly organized with attention to details and strong documentation skills
• Excellent verbal and written communication skills as well as technical writing skills
• Strong inter-personal skills and ability to collaborate with colleagues on project teams
• Able to complete routine and difficult work independently and perform assigned tasks
• Knowledge of standard pharmaceutical contracting process
• Good project management skills with the ability to multitask across several programs simultaneously and prioritize tasks based on project timelines

Desirable Skills/Experience

• Previous experience as Bioanalytical/Biomarker project representative experiences on clinical study teams is a plus.

When we put unexpected teams in the same room, we fuel ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we champion diversity in a patient-driven, energizing culture where people build connections to explore new ideas that profoundly impact patients’ lives. Here, diversity and different thinking are valued, so life-changing new ideas can come from everywhere. We celebrate and reward each other, ensuring kindness remains as important as our ambition to succeed for those in need. We take pride in giving back to the communities in which we operate.

Ready to make a difference? Apply now!

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 authorization and employment eligibility verification requirements.