BioNTech SE

• Define and execute Labeling strategy for global life cycle management of medicinal products in BioNTech's responsibility for Primary Reference Labeling (i.e., the Company Core Data Sheet (CCDS), US Prescribing Information (USPI) and EU CP Summary of Product Characteristics [SmPC]). • The strategy comprises management of local market label dependencies and country label differences when the local markets identify a need to review Primary Reference at the Labeling Team level • Build and lead cross-functional Labeling Teams • Responsible for timely preparation of Primary Reference labeling updates following update of the CCDS or on request of competent Health Authorities • Ensuring timely communication of updated CCDS content to local country offices for MAs in BioNTech’s responsibility • Lead development and maintenance of regulatory processes and systems for Global Labeling • Identify critical Regulatory Labeling issues and proactively implement activities for their resolution including leading initiatives for Labeling within GRA or across functions at BioNTech • Act as the empowered delegate for the Head of Global Labeling as necessary

Role Description You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products. In your role, you will act globally and work cross-functionally. At BioNTech, you will contribute to transforming the future of medicine while shaping a best‑in‑class Global Labeling function. You will work in an agile, science‑driven environment with: - High strategic visibility in a global role at the interface of science, regulation and patient impact - Close collaboration with senior leaders and cross‑functional experts across the organization - The opportunity to build and refine global labeling standards, processes and systems in a rapidly evolving portfolio - A culture that values ownership, innovation, integrity and continuous learning If you are passionate about advancing innovative therapies to patients worldwide and want to shape global labeling at scale, we look forward to receiving your application. Your contribution: - Define and execute Labeling strategy for global life cycle management of medicinal products in BioNTech's responsibility for Primary Reference Labeling (i.e., the Company Core Data Sheet (CCDS), US Prescribing Information (USPI) and EU CP Summary of Product Characteristics [SmPC]). The strategy comprises management of local market label dependencies and country label differences when the local markets identify a need to review Primary Reference at the Labeling Team level - Build and lead cross-functional Labeling Teams - Responsible for timely preparation of Primary Reference labeling updates following update of the CCDS or on request of competent Health Authorities - Ensuring timely communication of updated CCDS content to local country offices for MAs in BioNTech’s responsibility - Lead development and maintenance of regulatory processes and systems for Global Labeling - Identify critical Regulatory Labeling issues and proactively implement activities for their resolution including leading initiatives for Labeling within GRA or across functions at BioNTech - Act as the empowered delegate for the Head of Global Labeling as necessary Qualifications - Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent - Advanced degree preferred, but not required - 9-16 years of professional working experience in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules, including direct experience in strategic Labeling content development and management and interacting with Health Authorities - Profound experience in leading the preparation and revision of product prescribing (and corresponding patient) information during registration and/or post-marketing, for CCDSs, EU CP SmPCs and USPIs - In depth knowledge of EMA and FDA regulatory requirements for product prescribing and patient information - Ability to work independently on very complex projects with minimal oversight - Excellent verbal and written communication skills in English Benefits Expected Pay Range: $146,300/year to 234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. - Medical, Dental and Vision Insurance - Life, AD&D, Critical Illness Insurance - Pre-tax HSA & FSA, DCRA Spending Accounts - Employee Assistance & Concierge Program (EAP) available 24/7 - Parental and Childbirth Leave & Family Planning Assistance - Sitterstream: Virtual Tutoring & Childcare Membership - Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown - 401(K) Plan with Company Match - Tuition Reimbursement & Student Loan Assistance Programs - Wellbeing Incentive Platforms & Incentives - Professional Development Programs - Commuting Allowance and subsidized parking - Discounted Home, Auto & Pet Insurance - …and more! More details to be shared.

Southwest Coast, US; West Coast & Sierra, US | full time | Job ID: 11225 About the Role: Lead with Purpose, Shape the Future of Oncology Care Reporting to the Executive Director, US National Field Medical Head, Oncology, the Senior Director, Regional Medical Science Liaisons (MSLs) within our Oncology Medical Affairs organization, will play a strategic, high-impact leadership role responsible for elevating scientific exchange and accelerating advances in cancer care. You will lead, inspire, and develop a team of exceptional Oncology MSLs across the Western US — empowering them to build meaningful partnerships with scientific leaders, translate emerging clinical insights, and help drive our mission to improve outcomes in gynecological and breast cancers. This role is ideal for an experienced people leader who thrives at the intersection of science, strategy, and field team development. You’ll shape field medical strategy, influence clinical development, and foster a culture of excellence, collaboration, and innovation. Your contribution: - Build and develop a high-performing MSL team—recruiting top Oncology MSL talent, onboarding with intention, and providing coaching that fuels continual growth. - Lead with clarity and purpose by defining expectations, driving accountability to performance standards, and fostering a culture of continuous learning, innovation, and external awareness. - Strengthen partnerships across the oncology landscape, including scientific experts, investigators, research groups, and key external stakeholders. - Serve as a player-coach, maintaining select territory or account responsibilities to stay close to the field and model best practices. - Guide MSL team strategy and execution, ensuring alignment with broader medical plans and organizational objectives. - Foster excellence in documentation, compliant field medical activities, and industry-standard practices. - Identify and elevate key insights, trends, and unmet needs to help shape medical strategy and inform clinical development. - Act as a trusted point of escalation for field-related issues, collaboration needs, and HR matters. - Champion a culture of integrity, agility, and cross-functional collaboration across Medical Affairs. A good match: - Advanced scientific degree (PhD, PharmD, MD/DO) with 7+ years’ Oncology MSL experience, including 3+ years leading people. - Expertise in solid tumors, with strong preference for experience in Women’s Oncology (e.g., breast, gynecologic cancers) and lung cancer. - A proven ability to lead remote, distributed field teams with empathy, clarity, and accountability. - Strong communication, presentation, and stakeholder engagement skills. - Experience supporting clinical research, navigating healthcare compliance, and guiding medical strategy. - Ability to synthesize complex scientific information and communicate insights that influence decision-making. - Willingness to travel 50-70% in a field-based role. This role offers a unique opportunity to directly influence scientific exchange and patient impact across a critical therapeutic area. You will empower teams, shape strategy, and elevate the voice of the field—helping accelerate meaningful advances in cancer care. If you’re inspired by leadership, energized by scientific innovation, and driven to make a difference for patients and providers, this role offers an exciting platform to do your best work. Expected Pay Range: $198,900/year to $318,300/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Your Benefits: BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: - Medical, Dental and Vision Insurance - Life, AD&D, Critical Illness Insurance - Pre-tax HSA & FSA, DCRA Spending Accounts - Employee Assistance & Concierge Program (EAP) available 24/7 - Parental and Childbirth Leave & Family Planning Assistance - Sitterstream: Virtual Tutoring & Childcare Membership - Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. - 401(K) Plan with Company Match - Tuition Reimbursement & Student Loan Assistance Programs - Wellbeing Incentive Platforms & Incentives - Professional Development Programs - Commuting Allowance and subsidized parking - Discounted Home, Auto & Pet Insurance …and more! More details to be shared. Apply now - We look forward to your application! By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

• Lead feasibility assessments for global clinical trials, including site selection, patient population analysis, and competitive landscape assessment. • Develop country and site-level enrollment projections and timelines, ensuring alignment with protocol design and core project team objectives. • Build and maintain forecasting models to support scenario planning, resource allocation, and risk mitigation across the clinical portfolio. • Provide operational input during the protocol design phase, ensuring trials are executable, cost-effective, and aligned with core project team objectives. • Lead the adoption of advanced analytics, real-world data, and predictive modeling to inform feasibility and planning decisions. • Lead implementation and optimization of digital tools and platforms to enhance planning accuracy and efficiency. • Track clinical trial performance against expectations, identify areas for potential intervention, and advise cross-functional teams on clinical trial trade-offs across variables such as time, quality, and cost. • Participate in root cause analysis and develop mitigation strategies to address study execution and enrollment challenges. • Ensure the quality and integrity of feasibility assessments and operational plans, actively identifying and managing internal and external risks. • Support the QA team during internal audits, vendor audits, and/or hosting inspections as required.

• Lead one or multiple therapeutic platforms within BioNTech's pipeline, ensuring consistent execution across compounds and vendors • Drive cross-functional collaboration with internal departments, external vendors, and global partners to align strategies and achieve operational goals • Develop portfolio documents such as oversight plans, process developments (including Trial RACI), and SOPs to streamline operations • Supervise adherence to regulatory requirements, ICH-GCP guidelines, and internal procedures while ensuring proper training for team members • Provide operational insights into feasibility studies, timeline planning, and cost estimations during clinical program development • Act as a key escalation point for platform-level challenges while delivering innovative solutions for operational hurdles • Manage resource forecasting and allocation for clinical studies across programs while overseeing CTM/CTS staff recruitment, mentoring, training, and compliance.

• Responsible for the planning and strategic set-up of the Clinical Operations team • Accountable for the continuous adaptation of clinical operations needs and internal departmental processes • Represents clinical operations in interaction with international collaborations with pharma partners • Actively driving Governance Vendor Oversight for the main Clinical Research Organizations (CROs) • Oversees all aspects of clinical trial execution within a set of therapies • Initiation of development and review of portfolio documents • Supervision of the direct reports for adherence to regulatory requirements • Resource planning in alignment with GCDO and GDO

As Director of Clinical Trial Feasibility, Planning, and Analytics within Global Clinical Operations (GCO), you will play a pivotal role in shaping the future of clinical trials at BioNTech. Your work will directly contribute to optimizing operational planning and analytical support for global trials, ensuring alignment with our mission to revolutionize medicine through cutting-edge science. Lead feasibility assessments for global clinical trials, including site selection, patient population analysis, and competitive landscape assessment. Develop country and site-level enrollment projections and timelines, ensuring alignment with protocol design and core project team objectives. Build and maintain forecasting models to support scenario planning, resource allocation, and risk mitigation across the clinical portfolio. Provide operational input during the protocol design phase, ensuring trials are executable, cost-effective, and aligned with core project team objectives. Lead the adoption of advanced analytics, real-world data, and predictive modeling to inform feasibility and planning decisions. Lead implementation and optimization of digital tools and platforms to enhance planning accuracy and efficiency. Track clinical trial performance against expectations, identify areas for potential intervention, and advise cross-functional teams on clinical trial trade-offs across variables such as time, quality, and cost. Partner with CROs on ensuring alignment of assumptions and expectations around feasibility and performance of outsourced studies. Drive the evolution of BioNTech’s feasibility, planning, and analytics capabilities, strengthening internal ownership while optimizing the use of external partners. Establish and embed fit-for-purpose, cost-effective and scalable feasibility and analytics approaches that enhance internal decision-making. Serve as a key point of contact for clinical trial feasibility, planning, and analysis matters. Collaborate with peers in Clinical Operations and cross-functionally with Clinical Procurement, Vendor Management, Clinical Development, Medical Affairs, Regulatory and Project Management to support budgeting, resource planning, and trial prioritization. Participate in root cause analysis and develop mitigation strategies to address study execution and enrollment challenges. Ensure the quality and integrity of feasibility assessments and operational plans, actively identifying and managing internal and external risks. Support the QA team during internal audits, vendor audits, and/or hosting inspections as required. Adhere to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).

The Senior Director Global Clinical Operations is responsible for the planning and strategic set-up of the Clinical Operations team, including planning of required resources as well as relevant vendors and systems. The Sr. Dir leads the Clinical Operations team and is the point of escalation for the Director/Sr. Director Global Clinical Operations for clinical trial activities and line management tasks. Oversees all aspects of clinical trial execution within a set of therapies defined as a “portfolio” within BNT pipeline (includes multiple platforms). Highly skilled at strategic operational execution, effective communication with senior leadership as well as vendor & stakeholder management. Your Contribution: Accountable for the continuous adaptation of clinical operations needs and internal departmental processes for the rapidly growing organizations within BioNTech. Represents clinical operations in interaction with international collaborations with pharma partners and other collaboration partners. Actively driving Governance Vendor Oversight for the main Clinical Research Organizations (CROs) working for BioNTech, running steering committees and control activities to ensure the required compliance. Profound experience with the preparation and processing of national and international business experience in clinical operation and clinical development processes. Actively exchanging and communicating with upper management, related internal departments and external departments and collaboration partners. All clinical operations strategies need to be developed under consideration of the local laws, international guidelines (ICH GCP). Excellent communication and problem-solving skills are part of the job. Oversees activities related to leading the team, oversight of third-party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved. Initiation of development and review of portfolio documents such as Oversight Plans, Process Developments (including Trial RACI) and SOP development. Supervision of the direct reports for adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training. Opportune contact to upper management, Clinical Development and other departments. Instruction and supervision (line Management). Resource planning in alignment with GCDO and GDO. Involved in the governance structure and oversight with CROs and vendors. Contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors for strategic sourcing. Oversight on overall project/program timelines and deliverables and identification future of program needs. Team developments, performance management, identification of high-performance team members and working on team development together with GCDO LT. Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).