AstraZeneca

Role Description As an Implementation & Client Success Leader at Evinova, you are the accountable delivery lead, the primary point of contact for the customer on delivery, the person who holds the plan and the risk, and the one who ensures the team around you is coordinated and on track and that the customer stays confident. It is a hands-on role. This role is the engine that turns a signed contract into a live, adopted solution. You will be joining a team that is scaling. There is no fully established playbook to inherit. Part of this role is contributing to how we deliver and document what works, improving what doesn’t, and helping us get better as we grow. What You'll Do - Managing end-to-end customer implementations across your active portfolio, ensuring successful delivery throughout each stage of the process. - Owning the delivery plan, milestones, dependencies, and RAID log for each active study, maintaining clear oversight and accountability. - Coordinating with Solution Engineers, testers, and Product Engineering to ensure builds remain on track and delivery timelines are met. - Acting as the primary customer contact for delivery status updates, risk management, and escalations throughout the implementation lifecycle. - Identifying where product development timelines or release scope may create delivery risks, and managing those risks transparently with both customers and internal stakeholders. - Adapting the delivery approach across different deployment models, including forward deployed, guided, and self-serve. - Leading the hypercare closeout process, ensuring lessons learned are captured, handover is documented, and no unresolved post-go-live issues remain. - Contributing to the delivery playbook by documenting approaches, highlighting gaps, and supporting continuous team learning. Qualifications - Demonstrable track record of delivering SaaS implementations on enterprise platforms within regulated industries. - Experience delivering implementations while a product was still maturing, including managing implementation risk arising from adoption rates, customer readiness, and timelines. - Strong delivery discipline, with the ability to demonstrate a robust delivery plan, a well-maintained RAID log, and sound risk-based decisions made under pressure. - Experience managing multiple concurrent implementations across different deployment models. - Ability to maintain delivery quality in ambiguous environments where no established playbook exists. - Experience managing sophisticated customers with high governance standards, particularly in pharma, life sciences, or similarly regulated enterprise environments. - Proactively identifies and escalates risks early and directly, rather than downplaying them to protect relationships. - Communicates delivery status, product constraints, and timeline risks honestly and clearly, including when the message may be challenging. - Experience managing sponsor-side Digital and Data stakeholder relationships at programme level. - Builds trust through consistent delivery, rather than reassurance alone. - Sufficient technical literacy to lead engineers, interpret a data model, and understand integration dependencies, without necessarily being an engineer. - Comfortable engaging with Product Engineering on build sequencing, release scope, and configuration constraints. - Understands how AI-enabled product features influence implementation sequencing and data readiness. - Able to identify when a product gap requires escalation and articulate it clearly for both technical and non-technical audiences. - Brings structure to environments that do not yet have it, rather than waiting for an existing framework. - Uses AI tooling as part of their current workflow for delivery planning and project management, rather than viewing it as a future aspiration. - Comfortable contributing to process development while continuing to manage live delivery. - Resilient under competing pressures from customer, commercial, and product stakeholders simultaneously. Benefits - Competitive salary. - Excellent benefits. Company Description Evinova draws on AstraZeneca’s deep experience developing novel therapeutics, informed by insights from thousands of patients and clinical researchers. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment. Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector. Join us on our journey of building a new kind of health tech business to reset expectations of what a bio-pharmaceutical company can be.

Role Description The US Cell Therapy National Field Medical Director (NFMD) leads the field medical strategy for US Cell Therapy Medical Affairs. This role is responsible for shaping field execution, aligning teams around medical priorities, and ensuring strong connection between the field and headquarters. As a member of the Cell Therapy Medical Leadership Team, the NFMD partners closely with US Medical Affairs, Global Cell Therapy Medical Affairs, and cross-functional stakeholders to support the Cell Therapy portfolio. They bring field insights into strategy discussions and help translate company direction into clear priorities for the field team. This leader serves as both the voice of the field at headquarters and the voice of headquarters in the field. The NFMD is accountable for delivering business goals and key performance indicators, while owning the growth and evolution of the field-based MSL organization. This includes strengthening ways of working, refining processes, and driving best practices across the team. Typical Accountabilities: - Drive the development of high performing Regional Field Medical Directors (RFMDs) and Medical Science Liaisons (MSL). - Partner with Franchise Leadership to understand, develop, and implement National Field strategy for assigned therapeutic area. - Monitor and measure therapeutic area and priority ESE performance metrics. - Clearly communicate the impact of the Field Medical teams to senior leaders across the organization. - Ensure RFMDs demonstrate AZ Values through coaching and development discussions. - Ensure all new hires are trained in medical and field skills. - Set and drive appropriate capability development and professional progression across Field Team members. - Ensure RFMD and MSL compliance with AZ Compliance, SOPs, and US laws & regulations. - Collaborate with the Medical Heads, SM&M to develop TA plans to improve efficiency in clinical trials. - Coordinate and direct launch activities across field medical teams in alignment with TA plans and strategies. - Represent field medical team in multiple forums in HQ. - Hold teams accountable for driving business processes and plans. - Flag clinical and medical risks for HCPs and patients to appropriate HQ teams. - Identify and quantify field medical budget with a 3-year look forward. Qualifications - Bachelors degree in a relevant health science or clinical field, strong preference for a Pharm D, MD/DO, PHD, PA or NP. - 8 years of experience in the pharmaceutical space, ideally has 10+ years of experience. - 5+ years in field team management experience. - Ability to lead Medical Affairs activities in assigned Therapeutic Area. - Strong skills in coaching, leading, and management of people. - Effective communication skills at all levels of the business. - Strong business attitude and ability to balance cross-functional objectives. - Leadership experience in a matrix environment. - Effective networking and teamwork skills. - Solid understanding of the pharmaceutical governance environment. - Significant operational management experience. - Strong negotiation and strategic influencing skills. - Strong analytical and problem-solving skills. - Excellent analytical skills. - Strategic approach. - Demonstrated ability to prioritize. - An understanding of clinical development, and statistical design and analysis. Desirable Qualifications - Terminal degree, plus MBA. - Expertise in Field Medical and US Medical Affairs. - Experience in the assigned therapeutic area. - Expertise in Strategic Alignment of Medical Affairs External Scientific Expert Engagement Plan. - Strong knowledge of Medical Strategy and Clinical Development. - Experience in Product Launch Development and Execution. Benefits - Annual base pay ranges from $249,185.60 - $373,778.40 USD. - Short-term incentive bonus opportunity. - Eligibility to participate in equity-based long-term incentive program. - Qualified retirement program (401(k) plan). - Paid vacation and holidays. - Paid leaves. - Health benefits including medical, prescription drug, dental, and vision coverage. Company Description In our Oncology Business Unit, we change the practice of medicine and improve the patient experience by generating and communicating compelling medical evidence. We translate the wealth of medical and scientific expertise to ensure the data we produce helps physicians to better treat patients at every point in the journey. We are proud to work on the cutting-edge with one of the broadest and deepest Oncology pipelines in the business. Help to advance our pipeline by applying scientific expertise and accelerating our pathway to finding a cure.

• Develop and demonstrate knowledge of clinical disease states and treatment guidelines. • Effectively communicate product information to healthcare professionals. • Analyze trends and develop strategic business plans. • Provide solutions to customers by creating a tailored customer experience. • Identify opportunities for process improvement.

Role Description This is a fully remote role based in the United States. Ideal candidate will reside within the time zone of the support territory, though all qualified candidates will be considered. The hours for this role would be 8:30AM - 5PM EST. Role may require up to 10% travel to existing Alexion sites. Travel needs may be higher during new hire trainings and refresher trainings. The OneSource Support Specialist is a high-touch Patient Support Program (PSP) role within the Patient Services Department centered on delivering exceptional and personalized support to patients within the Alexion Rare Disease patient journey. Working as part of a Regional Care Team, the OneSource Support Specialist serves as the primary point of contact to patients and caregivers throughout their treatment journey from initial onboarding of product through long-term customized treatment adherence support. OneSource Support Specialist provide disease state education, treatment support through community connections, and access support for patients with rare and ultra-rare diseases. OneSource Support Specialist ensure patient treatment compliance and provide resolutions to non-clinical treatment issues for patients through communication and collaboration with both internal cross-functional partners and external stakeholders. You will be responsible for: - Providing exceptional initial onboarding experience and long term adherence support - Share materials on the disease, diagnosis, community resources and treatment support - Maintain and communicate up-to-date knowledge of the resources available as needed, including approved external resources - Place the required welcome calls to patients to introduce the OneSource program and confirm required/requested support - Communicate Benefit Investigation (BI) results with patients and HCP and help interpret them, as needed - Inform patient of financial support eligibility based on available programs - Enroll patient in Alexion financial assistance programs as eligible or refer to external support programs as appropriate - Proactively conduct routine and/or year-end reverification of coverage outreach by working with patients and caregivers, healthcare providers, insurance companies, and Alexion colleagues - Connect patients to the Alexion patient community and inform them about available advocacy groups for their disease - Assist patients in receiving required vaccinations either through Alexion or other vaccination locations - Efficiently navigate CRM documentation and other required record keeping during all patient interactions as to maintain high visibility into patient case status - Properly and immediately report Adverse Events during any customer interactions in the PV Event Reporting Tool - Act as the primary coordinator of all HCP needs across onboarding from case creation to product delivery and ongoing support through lifetime of product use - Coordinate with other appropriate HCP facing roles and cross functional partners to respond to questions from physicians and office staff and address any issues - Communicate with HCPs to confirm required/requested support or obtain missing information - Proactively and effectively consult with and engage the appropriate internal cross functional partners to resolve barriers quickly - Maintain working understanding of the reimbursement process, and leverage knowledge to communicate with internal and external stakeholders while insurance approval is being obtained and work with appropriate field specialists for denial/appeal support - Trigger initiation of adherence program on conclusion of onboarding and connect with patients through defined channels for the determined touchpoints based on product-specific programs - Educate prescribed patients and their caregivers regarding how to prepare for and what to expect during the long-term adherence of the Alexion product or switching from one Alexion product to another - Provide emotional support for patients and caregivers on continued administration of Alexion products Will also be crucial to: - Develop compliant and collaborative professional relationships with all relevant internal and external customers including but not limited to Patient Education Managers, Field Reimbursement Managers, Regional Account Managers, Customer Operations Representatives, Medical Accounts, Access Specialists, Specialty Pharmacies, Site of Care staff, and office coordinators - Effectively escalate access issues by informing the right stakeholders of actions to be taken to resolve any pending items in a timely manner - Collaboratively work with and share responsibilities with other Alexion members and external partners members for pull through of the target patient and HCP experience - Participate in any role appropriate cross functional collaboration work (e.g. Hypercare calls, regional cross functional meetings, One Alexion meetings) - Participate in other project work as needed Qualifications - Associates Degree or relevant work experience. - Minimum of 3 to 5 years Case Management OR recognized equivalent of education and experience (e.g. contact center, nursing, social service support, healthcare customer service, insurance reimbursement, patient advocacy, etc.) - Well-developed, effective communication, collaboration and problem-solving skills, as well as data entry/computer literacy skills - Ability to work independently, be goal-directed and have strong organizational skills - Must be flexible as well as easily adapt to a changing work environment which will require ongoing maintenance/training of job-related skills/activities - Must be willing to adjust work schedules in response to department needs. - The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, email, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. Requirements - BA/BS Degree is preferred; patient contact center or patient support program experience is a plus - Excellence at communicating over the phone and handling phone systems and/or experience in a call recorded environment - Familiarity with the relevant legal and regulatory components of the pharmaceutical and biotech industry - Rare disease experience a plus - Deep understanding of insurance coverage and reimbursement processes - Familiarity with managed care and particularly “buy and bill” therapy as well as with reimbursement for infused therapies - Experience dedicated to assisting patients/caregivers - Demonstrated success working within high performing cross-functional teams - Strong empathetic, communication and listening skills - Ability to act with urgency, flexibility, and creativity to quickly get patients on therapy - Strong organizational skills and ability to adapt to change and react constructively in a high-energy and fast paced environment - Demonstrates initiative, teamwork, and accountability Benefits - The annual base salary for this position ranges from $82,000 to $124,000. - Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. - Short-term incentive bonus opportunity. - Eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). - Qualified retirement program [401(k) plan]. - Paid vacation and holidays. - Paid leaves. - Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. - Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. - If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Role Description Cell Therapy Field Clinical Advisors (FCAs) are part of the Global Cell Therapy Clinical Operations team. They play a critical role in the successful execution of cell therapy clinical trials, driving recruitment, retention, and safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline engagement. We are looking for close collaboration with other CTCO Functions, Clinical Development, and Medical Affairs across multiple indications and departments to promote AstraZeneca's diverse cell therapy portfolio. You Will: - Pipeline mastery at scale: Build knowledge of AstraZeneca's cell therapy pipeline across multiple indications and assets. Convey AstraZeneca's cell therapy strategy, portfolio scope, and product differentiation; ensure compliant messaging across regions. - Systematically assess educational needs across owned sites, deliver advanced protocol training, and escalate patterns to Global Clinical Development with recommendations for enterprise solutions. - Capture applicable field insights (feasibility, operational bottlenecks, patient pathways) and deliver them to global and local partners to lead early risk identification and inform protocol/process adjustments. - Implement targeted protocol education (e.g., inclusion/exclusion criteria application) to lift enrollment rates, reduce screen failures, and minimize attrition. - Be the primary field point for protocol and clinical issues—evaluate and escalate, lead root-cause analysis, and implement corrective/preventive actions to reduce deviations and data queries. - Insight loop and continuous improvement: Systematically capture site-level insights, summarize trends for study teams and partners, and influence protocol/process adjustments and scaling. - Coordinate delivery across CTCO departments, Clinical Development, Medical Affairs, Supply/Logistics, Patient Operations, and Country Ops to ensure rapid, reliable service to partners and study sites. - Maintain current knowledge of local regulations, guidelines, codes of practice, and AstraZeneca policies; translate requirements into practical site actions and support inspection readiness. - Operate within AZ policies/SOPs and local regulations. - Directly improve the speed, quality, and consistency of AstraZeneca's cell therapy trials—reducing cycle times, elevating protocol adherence, and accelerating patient access to innovative treatments. Qualifications - Bachelor's degree in a health-related field required; advanced degree (PharmD, PhD, MSc, NP/PA, MD/RN) is preferred. - A minimum of 5 plus years in clinical research or field-facing roles within oncology/hematology or advanced therapies; direct cell therapy experience. - Concentrated understanding of GCP, clinical trial operations, and cell therapy patient journey. - Collaboration and Communication: Excellent partner management ability to translate complex protocols into practical site actions. - Ability to travel at least 50-80% regionally/nationally and internationally to support sites and program needs. - Patient- and site-centric mindset. - Data-informed approach to identify trends, risks, and opportunities for operational improvement. Benefits - A qualified retirement program [401(k) plan] - Paid vacation, holidays, and paid leaves - Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans. The annual base salary for this position ranges from $197,000 to $295,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Company Description 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.

Role Description Cell Therapy Field Clinical Advisors (FCAs) are part of the Global Cell Therapy Clinical Operations team. They play a critical role in the successful execution of cell therapy clinical trials, driving recruitment, retention, and safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline engagement. We are looking for close collaboration with other CTCO Functions, Clinical Development, and Medical Affairs across multiple indications and departments to promote AstraZeneca's diverse cell therapy portfolio. - Pipeline mastery at scale: Build knowledge of AstraZeneca's cell therapy pipeline across multiple indications and assets. Convey AstraZeneca's cell therapy strategy, portfolio scope, and product differentiation; ensure compliant messaging across regions. - Systematically assess educational needs across owned sites, deliver advanced protocol training, and escalate patterns to Global Clinical Development with recommendations for enterprise solutions. - Capture applicable field insights (feasibility, operational bottlenecks, patient pathways) and deliver them to global and local partners to lead early risk identification and inform protocol/process adjustments. - Implement targeted protocol education (e.g., inclusion/exclusion criteria application) to lift enrollment rates, reduce screen failures, and minimize attrition. - Be the primary field point for protocol and clinical issues—evaluate and escalate, lead root-cause analysis, and implement corrective/preventive actions to reduce deviations and data queries. - Insight loop and continuous improvement: Systematically capture site-level insights, summarize trends for study teams and partners, and influence protocol/process adjustments and scaling. - Coordinate delivery across CTCO departments, Clinical Development, Medical Affairs, Supply/Logistics, Patient Operations, and Country Ops to ensure rapid, reliable service to partners and study sites. - Maintain current knowledge of local regulations, guidelines, codes of practice, and AstraZeneca policies; translate requirements into practical site actions and support inspection readiness. - Operate within AZ policies/SOPs and local regulations. - Directly improve the speed, quality, and consistency of AstraZeneca's cell therapy trials—reducing cycle times, elevating protocol adherence, and accelerating patient access to innovative treatments. Qualifications - Bachelor's degree in a health-related field required; advanced degree (PharmD, PhD, MSc, NP/PA, MD/RN) is preferred. - A minimum of 5 plus years in clinical research or field-facing roles within oncology/hematology or advanced therapies; direct cell therapy experience. - Concentrated understanding of GCP, clinical trial operations, and cell therapy patient journey. - Collaboration and Communication: Excellent partner management ability to translate complex protocols into practical site actions. - Ability to travel at least 50-80% regionally/nationally and internationally to support sites and program needs. - Patient- and site-centric mindset. - Data-informed approach to identify trends, risks, and opportunities for operational improvement. Benefits - A qualified retirement program [401(k) plan] - Paid vacation, holidays, and paid leaves - Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans. Company Description 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.

Role Description The Regional Operations Director (ROD) position leads and manages the Associate Directors – Territory Operations Management (AD-TOM) assigned to their regions. You will oversee the expansion of the AZ cell therapy territories within your region ensuring agreement on company-wide goals, across multiple TAs for clinical and commercial cell therapy products. You will be responsible for your team performance and development. You have cell therapy operational and quality leadership and the ability to oversee a large portfolio across a dynamic landscape. The ROD will be a remote role reporting into the Executive Director, Cell Therapy Global Patient Operations. - Provide subject matter expertise (SME) in operational, clinical, and Site infrastructure for operationalizing AstraZeneca (AZ) cell therapy trials and commercial products to build a team and lead regional cross-functional activities with Internal Partners. - Lead a team of AD-TOMs assigned to territories within their region. - Develop and implement regional operational plans, collaborate across TAs to set targets and activation forecasts. - Develop and maintain relationships with key partners (MD, PA, RN, MLT, CQA, etc.) from the Sites responsible for establishing the service line to support AZ's clinical and commercial cell therapy goals. - Contribute to SOPs and Guidance Documents to provide a standardized approach to operationalize our cell therapy studies and commercial products and ensure quality parameters are met at the sites. - Foster relationships with HCPs and partnerships within the assigned region. - Provide leadership and mentorship to team members promoting their professional development. - Lead business change management and conduct process maturity assessment for Site Activation and post activation. - Analyze regional market and site dynamics and identify opportunities, roadblocks, and solutions across different therapeutic areas (hematology, solid tumors, rare disease, biopharma). - Work across the TAs with Clin Ops, SMM, Manufacturing, Supply Chain, Medical, IT leadership and others to support operationalizing and getting sites ready for the AZ cell therapy products. - Manage and contribute continuous improvements and development of solutions to deliver enhanced patient care experience during Site Activation, Post Activation and throughout the lifecycle of the cell therapy products. - Present Patient Operational reports and regional plans to senior management. - Maintain current knowledge of and follow established AZ activation goals, processes, regulatory standards, compliance, and procedures. - Follow AstraZeneca's core values, policies, and procedures. Qualifications - BA or BS degree in Nursing, Business, IT and Life Sciences or equivalent experience. - 8+ years of experience working within a Cell Therapy Program as Operational Champion/Other, healthcare/pharmaceutical environment, directly working with patients and/or healthcare providers. - Minimum 5 years of experience working in a Cell Therapy leadership role. - Develop and execute operational strategies in cell therapy. - Change management and ability to resolve complex problems promptly. - Flexibility in your schedule to provide support outside of regular business hours for emergent patient cases. - Willingness to travel domestically and internationally up to 50%. Desirable Skills - Demonstrated understanding of the healthcare customer environment and hospital regulations. - Experience working in a matrix organization with complex IT systems or portals that support customer service, health care scheduling, supply chain management, and call centers. - Familiarity with working in a heavily regulated, quality-control environment (e.g., following strict SOPs when available and extrapolating fundamental principles to situations not defined). Company Description 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.

Role Description Evinova is redefining how digital health accelerates clinical development, using an AI-native platform that already supports hundreds of active studies across more than 54 countries. At this pivotal moment of rapid global growth, the Chief Delivery Officer will build and scale the end-to-end delivery of our AI and SaaS solutions, ensuring that life-changing innovations reach patients faster, safely, and at scale. Reporting directly to the President and sitting on the Evinova Leadership Team, this role leads a global delivery organisation and holds executive accountability for quality, speed, compliance, and customer satisfaction across every deployment and engagement. - Lead the global delivery strategy and execution for Evinova’s AI and SaaS offerings. - Own and evolve a robust delivery framework that spans planning, kick off, deployment, launch, hyper care, continuous improvement, and upgrades. - Build and run a high-velocity “deployment factory” model using automation, AI, templates, and standardised playbooks. - Take full ownership of the professional services P&L, forecasting costs and margins. - Partner closely with Sales and Commercial teams to scope, price, and contract delivery commitments. - Track and report delivery financial performance to the Leadership Team and Board. - Act as the executive point of escalation for critical customer delivery issues. - Build positive relationships with senior customer partners. - Oversee customer success across the full post-sale lifecycle. - Own GxP-compliant delivery of all SaaS implementations and services. - Govern Computer System Validation (CSV), risk-based validation frameworks, and inspection readiness. - Define and enforce documentation standards, SOPs, and quality management practices. - Lead, develop, and encourage a distributed team of delivery professionals. - Drive transformation of delivery processes to increase capacity and reduce cycle times. - Set and manage OKRs, KPIs, and governance rhythms across the delivery organisation. - Partner with Product and Engineering leaders to feed delivery insights into the product roadmap. - Collaborate with People & Culture to define delivery competencies and a global talent acquisition strategy. - Represent Evinova externally as a recognised voice on delivery excellence in digital clinical development. Qualifications - 10+ years of progressive experience in delivery leadership within a global health-tech, eClinical SaaS, or life sciences professional services organisation. - Proven P&L ownership experience: budgeting, forecasting, margin management, and financial reporting. - Deep expertise in GxP-regulated software delivery. - Demonstrated experience leading and scaling a global delivery or professional services organisation of 50+ professionals. - Proven track record to design and operate high-velocity, scalable delivery models. - Strong executive presence and outstanding partner management. - Experience driving operational transformation. - Fluency in English (both written and spoken). - Ability to operate in a fast-paced, global, matrixed environment. - Degree or equivalent experience in related field. Requirements - Direct experience with eClinical platforms is highly valued. - Professional certifications such as PMP (PMI), PRINCE2, MSP or Agile/SAFe credentials. - Knowledge of CDISC standards (CDASH, SDTM) and their implications for clinical data delivery. - Experience applying Lean, Six Sigma or similar operational excellence methodologies. - Exposure to high-growth environments such as venture-backed or corporate spin-out health-tech businesses. Benefits - A purposeful role with real-world impact: improving how life-saving medicines reach patients faster. - A seat on the Evinova Leadership Team with direct influence on company strategy. - Competitive total compensation including base salary, annual performance bonus, and long-term incentive plan. - An inclusive, diverse, and internationally collaborative team environment.

• Contributes to the selection of potential investigators • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance • Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study • Trains, supports and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles • Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study • Ensures the sites are inspection ready at all times • Actively participates in Local Study Team (LST) meetings • Contributes to National Investigators meetings, as applicable • Initiates, monitors and closes study sites in compliance with AZ Procedural Documents • Shares information on patient recruitment and study site progress (site quality/performance) within the LST • Drives performance at the sites • Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate • Updates CTMS and other systems with data from study sites as per required timelines • Manages study supplies (ISF, etc), drug supplies and drug accountability at study site • Prepares study drug for destruction, if applicable • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan • If required, determines and discusses with LSAD the correct timing and type of visits • Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study • Ensures data query resolution in a timely manner • Works with data management to ensure robust quality of the collected study data • Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups • Prepares and finalises monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP • Follows up on outstanding actions with study sites to ensure resolution in a timely manner • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required • Assists site in maintaining inspection-ready ISF • Prepares for and collaborates with activities associated with audits and regulatory inspections in liaison with LSAD and CQAD • Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements • Supports/participates in regular QC checks performed by LSAD or delegate • Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF • Provides feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market • Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment) • Ensures compliance with local, national and regional legislation, as applicable • Collaborates with local MSLs as directed by LSAD or line manager

Role Description This is a fully remote role based in the United States. The hours for this role may vary depending on business coverage needed, however hours will default to 8:30 AM EST-5:00 PM EST. Role may require up to 10% travel. Travel needs may be higher for periodic trainings and/or as business needs. The Alexion Patient Services C5 OSS role is a key patient-facing role that supports OneSource Support Specialist responsibilities when there are gaps or other needs in territory coverage. This role will be responsible for executing on C5 task/activities spanning from patient welcome and enrollment to onboarding tasks, providing educational, logistical, and emotional support to patients through long-term adherence care plan tasks, to supporting onboarding and precepting of new OSS team members. The OSS may need to pivot daily between onboarding or adherence activities and/or be asked to work in a different territory day to day as determined by the current operational needs of the team or may be asked to support longer term coverage in a given territory. Strong prioritization skills, working with urgency and flexibility are key to success in this role. You will be responsible for: - Providing exceptional initial onboarding experience and long-term adherence support to patients - Sharing materials on the disease, diagnosis, community resources and treatment support - Maintaining and communicating up-to-date knowledge of the resources available as needed, including approved external resources - Placing the required welcome calls to patients to introduce the OneSource program and confirm required/requested support - Communicating Benefit Investigation (BI) results with patients and HCP and help interpret them, as needed - Informing patients of financial support eligibility based on available programs - Enrolling patients in Alexion financial assistance programs as eligible or refer to external support programs as appropriate - Proactively conducting routine and/or year-end reverification of coverage outreach by working with patients and caregivers, healthcare providers, insurance companies, and Alexion colleagues - Connecting patients to the Alexion patient community and inform them about available advocacy groups for their disease - Assisting patients in receiving required vaccinations either through Alexion or other vaccination locations - Efficiently navigating CRM documentation and other required record keeping during all patient interactions as to maintain high visibility into patient case status - Properly and immediately reporting Adverse Events during any customer interactions in the PV Event Reporting Tool - Acting as the primary coordinator of all HCP needs across onboarding from case creation to product delivery and ongoing support through lifetime of product use - Coordinating with other appropriate HCP facing roles and cross functional partners to respond to questions from physicians and office staff and address any issues - Communicating with HCPs to confirm required/requested support or obtain missing information - Proactively and effectively consulting with and engaging the appropriate internal cross functional partners to resolve barriers quickly - Maintain working understanding of the reimbursement process, and leverage knowledge to communicate with internal and external stakeholders while insurance approval is being obtained and work with appropriate field specialists for denial/appeal support - Triggering initiation of adherence program on conclusion of onboarding and connecting with patients through defined channels for the determined touchpoints based on product-specific programs - Educating prescribed patients and their caregivers regarding how to prepare for and what to expect during the long-term adherence of the Alexion product or switching from one Alexion product to another - Providing emotional support for patients and caregivers on continued administration of Alexion products Will also be crucial to: - Develop compliant and collaborative professional relationships with all relevant internal and external customers including but not limited to Patient Education Managers, Field Reimbursement Managers, Regional Account Managers, Customer Operations Representatives, Medical Accounts, Access Specialists, Specialty Pharmacies, Site of Care staff, and office coordinators - Effectively escalate access issues by informing the right stakeholders of actions to be taken to resolve any pending items in a timely manner - Collaboratively work with and share responsibilities with other Alexion members and external members for pull through of the target patient and HCP experience - Participate in project related work based on operational needs - Participate in any role appropriate cross functional collaboration work including but not limited to, acting as a liaison to other depts, facilitating and scheduling meetings and planning and preparing presentations - Support the orientation needs of new OneSource Support Specialists Qualifications - Associates Degree is required - Minimum of 1 year in Patient Services - Well-developed, effective communication, collaboration and problem-solving skills, as well as data entry/computer literacy skills - Ability to work independently, be goal-directed and have strong organizational skills - Must be flexible as well as easily adapt to a changing work environment which will require ongoing maintenance/training of job-related skills/activities - Must be willing to adjust work schedules in response to department needs Requirements - The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to: use a computer; engage in communications via phone, email, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. Benefits - The annual base salary for this position ranges from $86,663 - $129,950. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. - In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Company Description 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.