Alexion Pharmaceuticals, Inc.
Associate Director Translational and Biomarker Outsourcing
Alexion Pharmaceuticals, Inc., New Haven, Connecticut, us, 06540
Overview
Associate Director, Translational and Biomarker Outsourcing in Alexion R&D’s Translational Sciences group. You will manage vendor relationships, coordinate translational research-related assays, biomarker method transfers/validation, and ensure CROs 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 are key to driving our innovative research forward. You will be responsible for holding CROs accountable for results and deliverables per agreement as captured in communications and SOW proposals. Responsibilities
Lead in the identification and selection of the “right” CROs for the “right” bioassays and study objectives to support pre-clinical and clinical bio-sample testing. Integrate 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. 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, BMV, and ICH M10 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. Communicate effectively across departments in a timely fashion, in conjunction with Project Leads. Call out technical or logistical issues as appropriate within outsourcing and/or Alexion management. Essential Skills/Experience
Ph.D. with 10 years, MS degree with at least 15 years, or BS with a minimum of 20 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 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 and ICH M10 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 interpersonal 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. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Associate Director, Translational and Biomarker Outsourcing in Alexion R&D’s Translational Sciences group. You will manage vendor relationships, coordinate translational research-related assays, biomarker method transfers/validation, and ensure CROs 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 are key to driving our innovative research forward. You will be responsible for holding CROs accountable for results and deliverables per agreement as captured in communications and SOW proposals. Responsibilities
Lead in the identification and selection of the “right” CROs for the “right” bioassays and study objectives to support pre-clinical and clinical bio-sample testing. Integrate 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. 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, BMV, and ICH M10 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. Communicate effectively across departments in a timely fashion, in conjunction with Project Leads. Call out technical or logistical issues as appropriate within outsourcing and/or Alexion management. Essential Skills/Experience
Ph.D. with 10 years, MS degree with at least 15 years, or BS with a minimum of 20 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 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 and ICH M10 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 interpersonal 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. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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