Director Immunogenicity Sciences

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

This is what you will do:

As a member of thefast-pacedImmunogenicity Sciences group, you will be involved indevelopingstrategies to address scientific and regulatory priorities that should be integrated to understand and manage immunogenicity-related risks for the successful development ofa diverse pipeline ofbiotherapeutics.This will involveevaluating immunogenicitydata and assessing immunogenicityrisk forT-cell engagers(TCE)and cell and genetherapy programsduring preclinical and clinical phasesand where applicable devising mitigation strategies.Working closely with multiple departmentsacross Alexion and AstraZenecain a matrixedenvironment,you willcoordinate immunogenicity efforts to understand the impact of immunogenicity in non-clinical and clinical settings.

TheImmunogenicitySciencesDirectorwill be part of atalented, creative, collaborative team which is essential for the success of Alexion’s diverse portfolio of clinical trials. The Immunogenicity Sciences group is a globaldepartmentwithin the Clinical development, Regulatoryand Safety(DRS)organization, with colleagueslocatedin US,Canadaand Spain. The Immunogenicity Sciences groupmaintainshigh standardsof bioanalytical, immunology and immunogenicity excellence, leadership, quality, and compliance.

Strong leadership to create an environment and culture that constantly ensures compliance with internal procedures and processes set up by the Immunogenicity Sciences group and with current guidance documents from the FDA, EMA, and other regulatory agencies will be essential. The Director ofImmunogenicity Sciencesis accountable for interactions with regulatory agencies (especially EMAand MHRA) for specific issues on Immunogenicityassays, data interpretation, and for the Immunogenicity portions of IND, IMPD NDA/BLA/MAA, IB,study protocols, SAPs & CSRs, or other regulated documents. The leader willparticipatewith the rest of theclinical assetteam in devising strategies forregulatoryinteractions.

This individual will collaborate closely with Global Project Team Leaders(GPTLs), theTherapeutic-Area specific Clinical and Quantitative Pharmacology leaders,PatientSafety, Toxicologyand Bioanalytical to ensure prioritization are aligned with R&D priorities. Oversight, coaching, and mentoring of clinical team staff and Immunogenicity Sciences projectleadsfor interacting with Global Project Team Leads (GPTLs) and Clinical Project Leaders (CPLs) to enable Immunogenicity support for clinical trials will be essential. This roleis strategic andhas high visibility and high impact, with the ability to grow withinthe Global Immunogenicity Sciences group.

You willbe responsible for:

• Leading staff for the development of immunogenicity strategies for biologics, siRNA, peptides, gene therapy, cell therapy, TCEand emerging therapeutic modalities, including composition and review of Immunogenicity portions of IND, IMPD NDA/BLA/MAA, IB study protocols, SAPs & CSRs, or other regulated documents.

• Developingstrategies to address scientific and regulatory priorities that should be integrated to understand and manage immunogenicity-related risks for the successful development of biotherapeutics.

• Direct and reviewadaptive and innateimmunogenicityrelatedpre-clinical and clinicalassay development,datavalidation,documentationand its interpretation to assess immunogenicity risk and communicate to key stakeholders.This includesADA and neutralizingantibodyassays(includingcut point assessments), cellular immunogenicityassaysandassessmentofcytokines,complement factorsand other biomarkers linked to common adverse events.

• Help the entireImmunogenicityteamonthe visualization and interpretation ofImmunogenicityresults. By supporting, teaching, and providing examples to the members of the teamregardingtools for the visualization of immunogenicity results, excel and JMP. Helping to interpret and put into context the results obtained for different programs.

• Contribute to efforts associated with regulatory document preparation includingImmunogenicity Risk Assessment (IRA),integrated summary of immunogenicity (ISI), regulatory responses, Module 2 documents for IND and BLA submissions. 

• Liaising externally with keyopinion leaders inacademy,industryand regulatory agencies,participatingin scientific meetingsto externally influence and project scientific leadership in the fieldrepresentingAlexion position and rationale. Build relationships & collaborations with KOLs, academic partners,CROsand health authorities.

• Provide input on the Immunogenicity related sections of thecompany templates (CSR, IB, Protocol Concept Sheet, SAP)making sure that the wording for immunogenicity is aligned with the Immunogenicity Sciences group strategy and consistent across the different documents.

• Working closely withmembers oftheImmunogenicity Sciences group to ensure that theprocedures and processesarealways ready for compliance inspections by regulatory agencies.

• Stay current onthe immunogenicityassessment andneutralizingantibody assay methods.Maintain a thorough and current knowledge of the field landscape, literature, and regulatory guidanceto ensure that theImmunogenicity Sciencesgroup follows state of the artin Immunogenicity risk assessments and mitigationmethodologies,currentFDA/EMAassay standards for immunogenicitybioanalysis.

• Maintaining and controlling the project schedule, tracking progress made on tasks, andidentifyingactivities on the critical path and communicating the status of the project toappropriate stakeholders,organizing project teammeetingsand tracking action items to completion,identifyingissues and mitigation plans early and escalating appropriately.

• Support internal Immunogenicity trainingeffortby preparing training materials,coachingand mentoringjunior staff and other team members from various cross-functional groups.

• Participate in scientific review and due diligence activities of in-licensing candidate molecules, asappropriate.Provide input on theimmunogenicity-relatedrisks for theassetsunderconsideration andpropose mitigation strategies for the identified risks.Review the critical data related to Immunogenicity after the acquisition of the assets or companies.

You will need to have:

• MD (Allergy/Immunology/Pharmacology) or PhD in Immunology, Cell and Gene therapyor a related discipline withat least10 to 15 years of relevant post degree experience.

• 10+years ofhands-onworking experience inCell and Gene Therapy,Immunogenicity, Bioanalytical Sciences, or Clinical Pharmacology in Pharmaceutical industry, with strong emphasis and understanding ofImmunogenicity knowledge.Familiarity inGLP regulations,GxPdocumentation and immunogenicity regulatoryguidance’s.

• Exhibit professional maturity,confidence,and competence.

• Excellent verbal and written communication and strong presentation skills to summarize and communicate key points and businesscaseforimportant issuesimpactingprograms.

• Proven ability to work effectively and collaboratively as a member of a multidisciplinary team, withtrack recordof building strong and sustainable relationships with internal and external partners andstakeholders.

• Ability to synthesize and prioritize complex issues and data by applying conceptual thinking, analyticalthinking& problem-solving approaches today-todaybusiness challenges.

• Strong pedigree of publications in peer-reviewed journals,thought-leadershipin data analysis and presentation.

• Success in this role willalsobe evaluated by the ability to influence and inspire scientists in the organization, andmaintaina culture that encourages innovation, scientific rigor, and growth opportunities.

We wouldpreferfor you to have:

• Experience in the development of Cell therapies, ideally in CAR-T cell-based strategies.Prior experience of data analysis of clinical CAR data (FACS,multi-omics dataetc)is a plus. 

• A broader experience of clinical development(from Ph 1 to Ph3)of multiple modalities including but not limited tomAb, Gene Therapy, peptidetherapy,drug development andBLAor NDAsubmissions. 

• Experience with F2F meetings with regulatory authorities andcreatestrategies andresponsesfor regulatoryquestionson pre-clinical and clinical sections associated with immunology and/or immunogenicity. 

• Prior experience as a reviewer inImmunogenicityor ClinicalPharmacologyat any of the European regulatory agencies will be highly desirable. 

• A proventrack recordof external influence through podium presentations at key global meetings like AAPS -NBC, AAPS-360, or the European Immunogenicity Platform (EIP), etc.

• Knowledge of predictive algorithms and In vitrocell basedrisk assessment tools for biologics optimization and for minimizing immunogenicity risk isa plus.

• Exposure or training in AI tools associated with drug development and data analysis is a plus.