Job Description Summary Location: DWA. The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific East Hanover site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 25% travel. Full time Novartis will not sponsor Visas for this position and location. At Novartis, we are re imagining how clinical trials are designed, delivered, and scaled—placing digital, operational data and AI at the heart of execution. As Head of GCO Technology & AI, you will define and lead the end to end technology, operational data and AI strategy for Global Clinical Operations (GCO), shaping how innovation translates into faster, higher quality outcomes for patients worldwide. Job Description This is a high visibility, enterprise‑shaping leadership role, accountable for leveraging technology and AI-driven solutions in transforming clinical operations. You will lead large‑scale transformation in a GxP‑regulated environment, balancing ambition with pragmatism—delivering solutions that work at scale and drive measurable business impact. Your purpose You will ensure that GCO is equipped with modern, secure, compliant and scalable digital capabilities, enabling world‑class clinical delivery, operational efficiency and data‑driven decision‑making. Partnering closely with GCO Leadership, enterprise Technology and AI teams, and key external partners, you will industrialize AI, clinical technology and analytics solutions that enhance execution, strengthen quality and accelerate cycle times across the clinical portfolio. Key responsibilities Strategic leadership & transformation - Define and execute the multi‑year GCO digital, operational data and AI strategy, aligned with Novartis enterprise priorities. - Serve as a trusted advisor to the GCO Leadership Team on digital transformation, AI enablement, automation and technology investment decisions. - Lead a major transformation agenda, shifting manual, fragmented processes into AI‑enabled, orchestrated workflows at scale. Technology, data & AI delivery - Own delivery across six core capability pillars, including AI delivery, data analytics and visualization, technology platforms supporting study, site and clinical data operations, and metadata standards and integration. - Identify, prioritize and industrialize high‑value AI and GenAI use cases in a regulated environment, ensuring measurable outcomes. - Oversee platform roadmaps, vendor partnerships, cybersecurity, data privacy, and quality standards across the GCO technology landscape. People & change leadership - Lead and inspire a global organization of ~80 professionals across AI, operational data, analytics and technology platforms. - Build future‑ready capability in AI, data science, analytics and platform leadership. - Drive change management with a strong people focus—leading through influence in a complex, matrixed environment where adoption is as critical as technology. Operational excellence & compliance - Ensure reliable, on‑time and within‑budget delivery of GCO technology and AI initiatives. - Maintain full compliance with GxP, data integrity, cybersecurity and regulatory requirements. - Establish scalable governance models, operating frameworks and cross‑functional ways of working to support global execution. What you will bring Experience & expertise - 10+ years of senior leadership experience in digital, data or technology roles within pharma, CRO, biotech or other highly regulated industries. Experience working within a GXP-regulated environment is essential. - Deep understanding of clinical operations systems (e.g. CTMS, eTMF, RTSM, clinical data platforms). - Proven track record of scaling AI / ML solutions in regulated environments, with strong delivery and change outcomes. - Excellent track-record of delivering large-scale digital transformations - Strong knowledge of drug development and GxP standards. - Demonstrated success leading large, global, multidisciplinary teams and enterprise‑level transformation programs. Leadership capabilities - Change‑first mindset—able to inspire, influence and bring people through transformation. - Strategic yet pragmatic, with a strong execution bias and focus on outcomes. - Exceptional communication skills with the credibility to partner with senior leaders in a high support, high challenge environment. - High emotional intelligence and the ability to lead through complexity and ambiguity in a matrix environment. Education - Advanced degree in Technology, Data Science, Engineering, Life Sciences or equivalent. - MBA or equivalent leadership qualification is advantageous. The salary for this position is expected to range between $248,500 and $461,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $248,500.00 - $461,500.00 Skills Desired AI Adoption, AI Agents, AI Integration, AI Systems, Artificial Intelligence (AI), Artificial Intelligence Technologies, Change Management, Change Process Management, IT Change Management

Protecting our tomorrow Job Title: Head of Clinical Operations & Biometrics Location: US Remote; East Coast Strongly Preferred Department: Research & Development Reports To: Senior Vice President, Research & Development Salary Range: $310k - $360k About Bavarian Nordic At Bavarian Nordic, we are dedicated to protecting lives and advancing global health through innovative vaccines. As a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, chikungunya, cholera, and typhoid. Our mission is simple: to improve quality of life worldwide by preventing infectious diseases. We are headquartered in Denmark and have offices across Europe and North America. Position Overview The Head of Clinical Operations & Biometrics is accountable for planning, executing, and delivering Bavarian Nordic’s global clinical trial portfolio. This role oversees Clinical Operations, Data Management, Biostatistics, Medical Writing and Statistical Programming, ensuring high-quality, compliant, and efficient clinical development execution. Key Responsibilities - Develop and execute the overall clinical operations strategy across Phase I–IV trials - Build and lead a high-performing cross-functional organization covering Clinical Operations, Biometrics, Medical Writing and Vendor/CRO Oversight - Contribute to corporate development strategies and clinical trial design decisions - Ensure ICH-GCP compliance, and audit/inspection readiness - Ensure clinical trials meet targets for timeline, budget, quality, and enrolment - Own functional and study budgets, forecasting, and resource planning - Oversee and set up governance for CRO partnerships - Ensure robust data capture strategies, database design, cleaning processes, and database lock in alignment with study timelines - Oversee development, validation, and documentation of data standards (e.g., CDISC). - Oversee statistical design of trials, statistical analysis plans (SAPs), endpoint justification, and modelling - Ensure regulatory-grade statistical outputs and programming deliverables (TFLs, CSR outputs, submission datasets) - Build capabilities, develop talent, and mentor clinical operations and biometrics leaders and foster a culture of quality, accountability, and operational excellence Qualifications - Advanced degree in Life Sciences, Biostatistics, Public Health, Medicine, or related field (PhD, MSc, MPH, MD preferred) - 15+ years in clinical development within biotechnology or pharmaceutical industries. At least 5 years in a leadership position - Proven leadership of Clinical Operations and Biometrics functions - Experience managing global Phase I–III trials; vaccine or biologics experience highly preferred - Demonstrated success collaborating with regulatory authorities - Strong understanding of ICH-GCP. Knowledge of CDISC standards, and statistical methodologies is a plus - Strategic thinking with hands-on operational mindset - Ability to influence in matrix environments and manage external partners - High adaptability and comfort working in fast-paced biotechnology setting with multiple parallel priorities - Strong financial acumen with experience overseeing department and study budgets - Ability to travel globally up to 30% Why Join Us Join a passionate, mission-driven global biotech committed to protecting lives. At Bavarian Nordic, you’ll find a collaborative culture, flexible work environment, and opportunities for ongoing professional development and growth. Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. For more information, visit www.bavarian-nordic.com #LI-MA1

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Clinical Affairs Specimen Operations Manager (CASO) works with cross functional support teams and key stakeholders to support the logistical stand up of all clinical studies and ensure that supply and sample management needs meet the study design requirements. This role will facilitate the project milestone development, facilitate teams to execute and communicate to the broader organization. The Project Manager, CASO supports the clinical study portfolio for Exact Sciences commercial and pipeline products, collaborating with Product Core Teams and their respective working groups to successfully meet the development, evidence generation and overall strategic needs of each Exact Sciences product. This position is remote. Essential Duties Include, but are not limited to, the following: - Develop operational relationships with cross functional team members including but not limited to Clinical Laboratories, Regulatory Affairs, Research and Development, Program Management, Biorepository and others as appropriate. - Lead defined small and medium-sized projects and components of large projects/programs. - Coordinate all activities required for supply and sample management set up for internal and external clinical studies. - Liaise between internal and external stakeholders and Exact Sciences team members. - Coordinate and provide communication updates to key stakeholders, management, and team members. - Lead and support process improvement initiatives within clinical and regulatory affairs. - Analyze systems user needs to identify and communicate efficiencies/gaps cross-functionally. - Assess cross-functional impact and integrate stakeholder recommendations/needs to streamline process flow. - Visualize and document processes. - Define and report on metrics that are indications of the health of the day-to-day sample and data elements supporting clinical studies. - Improve the metrics and tracking that feed overall study performance to make decisions on usable samples/subjects, enrollment projections, and advancement of the forecasting process that is required to support study logistics. - Assist teams with breaking project work into manageable packages and organizing into a project schedule. - Keep related information organized and available to appropriate stakeholders and team members. - Manage issues and action items by collaborating directly with team members to ensure completion. - Maintain positive working relationships with various internal parties and stakeholders. - Assign tasks and confirm completion. - Ensure on-time delivery of all assigned goals. - Schedule meetings and prepare agenda and minutes at the direction of stakeholders and collaborators. - Strong attention to detail. - Ability to organize, present, and convey problems or issues. - Manage multiple priorities for various stakeholders in a cross-functional matrix environment. - Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests. - Strong verbal and written communication skills. - Effective presentation skills. - Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity. - Analytical, problem solving and decision-making skills. - Ability to coordinate multiple tasks both owned individually and by others. - Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. - Support and comply with the company’s Quality Management System policies and procedures. - Maintain regular and reliable attendance. - Ability to act with an inclusion mindset and model these behaviors for the organization. - Ability to lift up to 10 pounds for approximately 5% of a typical working day. - Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. - Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height. - Ability to work on a computer and phone simultaneously. - Ability to comply with any applicable personal protective equipment requirements. - Ability and means to travel between local Exact Sciences locations. - Ability to travel 10% of working time away from work location, may include overnight/weekend travel. Minimum Qualifications - Bachelor’s degree in the health or life sciences, or a field as outlined in the essential duties, or Associate’s degree in the health or life sciences and 2 years of experience in a field as outlined in the essential duties in lieu of Bachelor’s degree, or High School Degree/General Education Diploma and 4 years of experience in a field as outlined in the essential duties in lieu of Bachelor’s degree. - 5+ years of experience in a Clinical, IT, or Regulatory role, or a field as outlined in the essential duties. - 3+ years or experience in a project management support role. - Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook. - Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time. - Demonstrated ability to perform the Essential Duties of the position with or without accommodation. - 3+ years of experience in a project management support role. Preferred Qualifications - 2+ years of experience in process and workflow design, and process improvement. - Certified Associate in Project Management (CAPM) through PMI. - Strong understanding of FDA regulations and ICH GCP. Understands global regulations. Good understanding of clinical systems functionality and requirements. #LI-AN2 Salary Range: $76,000.00 - $125,000.00 The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible. Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits. Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here. Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.

Mgr, Clinical Operations | Full Service | CRA Line Management + CRA Monitoring Experience Required (Home-Based - Central and Western Region of US) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Core Responsibilities: • Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling May be involved in assignment of project work and will review workloads for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. • Review workload for all staff in reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced and staffing needs are identified in a timely fashion. • Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others. • Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively work to ensure staff retention and turnover rates remain within expected levels. • Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP. Ensure all staff follow required training and complete required documentation. Provide regular updates to management accordingly. • Work closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors. Able to contribute to BU level process improvements. May provide business development support. • May conduct several types of sign off and assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies. Ensure staff adhere to training guidelines, training records maintenance, and individual and corporate training needs are identified and addressed. • Organize and chair clinical staff meetings at regular intervals. Manage issues and provide follow up for action items requiring resolution. • Facilitate and support project and team/country reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Use department systems, reports, and dashboards to identify performance issues, process gaps and monitor overall performance progress in line with departmental goals and metric targets. Oversee all quality control efforts of assigned teams. Additional Qualifications: • Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required. • Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements • Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade. • Strong time management, technical and organizational skills. Ability to work independently and within a team environment. • Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets. • Must demonstrate good computer skills and be able to embrace modern technologies. • Ability to travel as necessary (up to 25%) At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $95,000.00 - $175,700.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.