CRO Manager, Bioanalytical and Biomarker Development - R&D
Alexion

Location: Onsite at either, Boston -Seaport, Cambridge, MA or New Haven, CT.

Alexion (AstraZeneca Rare Disease) is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and marketed Soliris® (eculizumab) and Ultimoris® as treatments for patients with PNH, aHUS and gMG. Alexion is evaluating other potential indications for Soliris® and Ultimoris® in additional severe and ultra-rare disorders and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. Further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.

Position Summary

The CRO Manager is a scientist with vendor management responsibilities in Alexion R&D's Bioanalytical and Biomarker Development group. BA CRO Manager facilitates the operational and logistical aspects of Bioanalysis providing support for multiple projects across multiple CROs. The main responsibilities include oversight of bioanalytical/biomarker outsourced work, assisting identification, selection, and general management of CROs following the guidance of Alexion's broader vendor management SOP(s). The CRO manager assists regular interactions with CROs and also is charged with establishing reasonable timelines at study initiation, as well as providing the oversight to meet those timelines.

Principal Responsibilities

• Maintains a clear and comprehensive understanding of Alexion procedures related to outsourcing and vendor management.
  
• Assists identification of and contracting with bioanalytical and biomarker CROs to support pre-clinical and clinical trials' bioanalytical 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 bioanalytical assays at CROs
  
• Oversee the design and execution of work to be performed at CROs, using established methods, with an understanding of the timelines and how the activities fit into a larger project framework
  
• Ensure that CROs follow BMV/GLP/GCP for regulated bioanalyses
  
• Works closely with and provides support to Alexion Global Strategic Sourcing (GSS) and Legal to ensure GLP tox and clinical trial-supporting contracts are in place and in alignment with study plans and protocols while best serving Alexion's interests.
  
• Ensures project timelines are met via communication and mitigation of risks, vendor tracking, and ensuring vendor transparency during project execution.
  
• Effectively and clearly communicates cross-functionally in conjunction with BA Project Leads in support of Clinical trials.
  
• Assist regular interactions with CROs to facilitate any outsourced activities
  
• Uses strong communication skills to negotiate technical details and timelines with CROs; strives to achieve project deadlines. Effectively holds vendors accountable for high quality data and associated timelines
  
• Able to effectively and clearly communicate across departments in a timely fashion, in conjunction with BA Project Leads
  
• May represent function in clinical study teams, facilitating operational execution of study Bioanalysis
  
• Escalate, when technical or logistical issues necessitate, as appropriate within CRO and/or Alexion management
  

Qualifications

• Experience working with bioanalytical/biomarker CROs and ability to facilitate Sponsor-CRO interactions.
  
• Experience with bioanalytical method development on LBA and/or LC-MS/MS platforms. Molecular assay experience is a plus.
  
• Experience with the operational execution of Bioanalysis 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 willingness to collaborate with colleagues on project teams
  
• Able to execute routine to difficult work independently and perform assigned tasks
  
• Can 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
  
• Bioanalytical project representative experiences on clinical study teams is a plus.
  

Education

• Ph.D. with 5 years, or 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.
  

Date Posted
14-Jan-2025

Closing Date
23-Jan-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.

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