CRO Senior Manager, Translational and Biomarker Development at Alexion in New Haven, Connecticut

Job Description:

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 biomarker method development, and ensuring the successful execution of clinical and pre-clinical biosample analyses. Expertise in regulated bioanalysis and ability to navigate complex projects will be key to driving our innovative research forward.



Accountabilities

• Maintain a clear and comprehensive understanding of Alexion procedures related to outsourcing and vendor management


• Assist in the identification of and contracting with biomarker CROs to support pre-clinical and clinical trials' biosample analyses services while effectively integrating these services into Alexion's global operations


• Participate in discovery and/or development projects leading to qualification/validation of fit-for-purpose assays at CROs


• Lead all aspects of the design and execution of work to be performed at CROs, with an understanding of the timelines and how the activities fit into a larger project framework


• Ensure that CROs follow GCLP and BMV guidance for regulated Bioanalysis


• 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


• Ensure project timelines are met via communication and mitigation of risks, vendor tracking, and ensuring vendor transparency during project execution


• Effectively and clearly communicate cross-functionally with Translational Science Project Leads in support of Clinical studies


• Assist regular interactions with CROs to facilitate any outsourced activities


• Use strong communication skills to negotiate technical details and timelines with CROs; strive to achieve project deadlines. Effectively hold vendors accountable for high-quality data and associated timelines


• Able to effectively and clearly communicate across departments in a timely fashion, in conjunction with Project Leads


• May represent function in clinical study teams, facilitating operational execution of study


• Escalate, 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' relevant 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 on LBA and/or 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


• Solve complex problems involving multiple functions


• Knowledge of standard pharmaceutical contracting process


• 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 unleash bold 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 are driven by our commitment to serve patients. Our work is guided by their experiences, allowing us to tackle the toughest challenges with empathy and innovation. Our culture fosters growth, collaboration, and a deep connection to our mission. Here, your career is more than just a job; it's an opportunity to make a meaningful impact on the lives of those living with rare diseases.


Ready to join us on this exciting journey? Apply now!



Date Posted

03-Jan-2025



Closing Date

30-Mar-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. Apply Now