BioNTech SE

• Support U.S. sales and use tax compliance, including return preparation, filings, and payments
• Assist with nexus analysis, taxability determinations, and exemption certificate management
• Support sales and use tax audits and respond to information requests
• Assist with U.S. federal and state income tax compliance, including data gathering and review
• Support income tax provision calculations under ASC 740 / IAS 12
• Prepare and review workpapers supporting taxable income, book-to-tax adjustments, tax attributes, and state apportionment
• Support treasury-related tax matters, including intercompany financing, cash repatriation, and funds flow planning
• Assist with tax analysis related to intercompany loans, interest, and withholding considerations
• Ensure intercompany invoicing processes are consistent with transfer pricing policies
• Support legal entity structuring, tax planning, business expansions, and operational changes
• Assist with process improvements, automation, and documentation of tax procedures
• Coordinate with local and global stakeholders to operationalize business changes
• Support local tax transformation projects, including process re-engineering, technology implementation, and data analytics
• Collaborate with stakeholders to identify opportunities for improvement and innovation of the local tax function
• Partner with IT & Global Tax to integrate tax systems with other business applications

Manager – US Tax

Director

• Provide technical analytical expertise in the field of potency assays for late-stage and commercial projects across a global network
• Responsible for the design and performance of method validation and transfer strategies as well as method lifecycle activities
• Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners
• Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products
• Act as analytical SME by providing expert knowledge for regulatory filings

Associate Director, Potency Assays – AS&T Lifecycle Management

• Lead and manage a team of medical professionals representing Clinical Development within global teams.
• Oversee the design and execution of clinical trials.
• Supervise the creation of integrated evidence generation plans.
• Represent BioNTech in collaborations with industry partners and advisory meetings.
• Provide medical expertise across multiple functions.

Executive Director, Clinical Development – Oncology

• Develop and implement policy and government affairs strategies in priority markets, focusing on Germany, France, Italy, and Spain (EU4).
• Monitor healthcare policy trends and regulatory developments to identify opportunities and risks.
• Collaborate with country teams to establish networks of external stakeholders for advocacy efforts.
• Represent BioNTech in industry associations and public forums to promote access to healthcare innovation.
• Partner with cross-functional colleagues to integrate policy considerations into R&D and regulatory strategies.
• Build relationships with government officials, advocacy organizations, and thought leaders to advance policy priorities.

Director, Global Access Policy and Government Affairs

• Build and execute a global patient engagement roadmap that aligns with corporate goals
• Identify, prioritize, and cultivate relationships with international patient organizations, advocacy groups, and key opinion leaders
• Ensure worldwide consistency in messaging, positioning, and ethical standards
• Partner with global functions such as Medical, Clinical, Commercial, Market Access and HEOR teams to integrate patient perspectives into study design
• Establish a harmonized framework for stakeholder mapping, collecting, documenting, and disseminating patient insights

Senior Director, Global Patient Engagement, Advocacy – Excellence Lead

• Lead major workstreams or strategic pillars within an oncology asset, indication, or disease-area strategy
• Translate scientific and clinical data into strategic recommendations and medical priorities
• Define or co-lead evidence generation priorities for specific pillars such as scientific communications, insight generation, publications, HEOR integration, or launch-related medical planning
• Represent Medical Affairs in relevant cross-functional forums and drive alignment across key stakeholders
• Support development and refinement of medical plans and key scientific narratives
• Partner closely with Development, GPS, Scientific Communications, Publications, HEOR, and country or regional medical teams
• Coach junior colleagues and contribute to functional capability building

Senior Director, Global Medical Affairs

Compliance

• Create and manage validation documents in accordance with SOPs, regulatory requirements, and industry guidelines
• Apply technical, functional, business, and industry knowledge to guide teams within the department and support decision-making
• Drive complex projects across departments, ensuring alignment with organizational objectives
• Act as the main point of contact for validation issues, collaborating with various stakeholders and supporting the audit process
• Oversee quality investigations and contribute to the department’s strategic direction, focusing on continuous improvement
• Leverage technical expertise to address complex validation challenges across clinical systems
• Be innovative and apply conceptual thinking to implement compliant and effective solutions that enhance cross-functional efficiency and maintain regulatory standards
• Guide projects spanning multiple groups, influencing direction and allocating validation resources for successful outcomes that meet organizational goals
• Run Audit readiness Program to get the department Inspection ready to reduce potential findings

Associate Director – Digital Systems Compliance

• Design and/or manage a strategy and proactive risk-based quality oversight program for vendors
• Manage the vendor qualification process and ensure the vendor qualification database is maintained
• Ensure vendor oversight after qualification through execution of quality assurance agreements, QA-QA calls, etc.
• Lead a team of QA personnel across multiple geographic locations
• Maintain strong relationships with internal and external stakeholders
• Ensure adherence to departmental procedures and that documentation produced under SOPs is inspection-ready
• Establish and maintain relevant KPIs
• Support inspection activities as requested

Associate Director, Vendor Compliance Management

Attorney

• Lead and manage diverse dispute resolution actions, including product liability cases, from pre-dispute steps to enforcement of judgments and awards
• Review pleadings and court documents with precision while handling subpoenas and information requests
• Conduct legal/business risk assessments during negotiations, including advising on jurisdiction and applicable law
• Manage external counsel relationships effectively to ensure strategic alignment, quality work products, and budget adherence
• Collaborate with internal stakeholders across departments (in particular, business development and alliances, research, clinical and technical operations and supply) to analyze relevant facts and documents for legal matters
• Support public disclosures such as SEC filings
• Develop and improve standard agreements, legal processes and training

Director, Legal Dispute Resolution – Government Investigations

Medical Director

• Design and implement innovative medical affairs strategies and plans for BioNTech’s oncology portfolio
• Provide expert medical and scientific insights to cross-functional teams, including Clinical Development, Regulatory Affairs, Commercial, Market Access, and Safety
• Develop and execute impactful medical education strategies, programs, and materials targeted at healthcare professionals
• Act as a medical/scientific spokesperson at advisory boards, educational events, and internal meetings
• Build and maintain relationships with external experts, medical societies, and patient advocacy groups in oncology
• Offer medical input into clinical development plans, study protocols, and operational documents to ensure alignment with goals

Medical Director, Lung Focus

• Work alongside the Head/Sr. Director of Statistical Programming as portfolio lead for the Infectious Diseases therapeutic area (e.g., COVID‑19, malaria, monkeypox, HIV, HSV, tuberculosis), implementing a comprehensive statistical programming strategy that maximizes efficiency and quality across the portfolio while ensuring alignment with corporate and regulatory requirements
• Oversee statistical programming deliverables across multiple Infectious Diseases programs and studies (early- and late-stage), including analysis datasets (e.g., SDTM, ADaM), tables, listings, and figures (TLFs), integrated summaries, and other regulatory deliverables.
• Ensure programming strategies are aligned with compound/platform objectives, indication‑specific needs, and regulatory expectations
• Lead the programming contribution to global regulatory submissions (e.g., NDAs, BLAs, MAAs, rolling submissions, emergency use authorizations) for Infectious Diseases assets, ensuring compliance with eCTD requirements, and high‑quality, submission‑ready datasets, TLFs, and documentation (e.g., define.xml, reviewers’ guides)
• Develop and oversee data standards, tools and automation for efficient production and verification of derived datasets (e.g., SDTM and ADaM) and TLFs, including portfolio‑wide solutions for recurrent endpoints (e.g., virology, immunogenicity, efficacy and safety outcomes) in infectious diseases
• Drive the creation, review, and validation of SAS/R programs for clinical data analysis across multiple infectious disease studies and integrated analyses, ensuring compliance with SOPs, regulatory standards, and principles of reproducibility and traceability
• Collaborate cross‑functionally with Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Translational Medicine, and other stakeholders to meet project deliverables and timelines for statistical data analysis and reporting across the Infectious Diseases portfolio
• Represent statistical programming in clinical study teams, portfolio governance, protocol reviews, and submission readiness meetings
• Guide and collaborate with internal Global Biometric Sciences (GBS) project leads and CRO/FSP staff to ensure alignment with established data, analysis, and quality standards.
• Provide direction and oversight to external partners delivering programming services for Infectious Diseases projects
• Champion the adoption of advanced analytics, automation tools (e.g., SAS macros, R/Python workflows), and new technologies (e.g., AI/ML, data visualization, decentralized trials, real‑world evidence) within the Infectious Diseases portfolio to enhance programming efficiency and scientific insight

Director Statistical Programming – Infectious Diseases

• Support the implementation of a global statistical programming ecosystem aligned with company goals and regulatory requirements
• Lead or co-lead initiatives to improve efficiency and standardize programming deliverables across studies and therapeutic areas
• Design, implement, and maintain statistical computing environments (SAS/R/Python/cloud-based platforms) to support clinical trial needs
• Develop reusable macros, scripts, and automation pipelines for SDTM/ADaM dataset generation and TLF production
• Evaluate emerging technologies (e.g., AI/ML models, cloud-native tools) for integration into statistical programming workflows
• Collaborate with IT infrastructure teams on environment optimization and incident resolution
• Establish governance frameworks for code quality, documentation, version control, and reuse of standardized components
• Provide technical leadership and mentorship to programmers on advanced techniques and tools

Associate Director, Statistical Programming

Communications

• Build and lead an integrated scientific communications organization that spans early development (Phase I) through to late-stage development and prelaunch/launch activities.
• Oversee a team of medical writers dedicated to early clinical publications and a scientific communications team focused on later-stage development.
• Develop and lead the global scientific communications strategy across the full product lifecycle, from Phase I through commercialization.
• Establish and optimize processes, standards, and governance for scientific communications, including publication planning, data disclosure, and scientific messaging.
• Serve as a key member of cross functional leadership teams (e.g., Clinical, Medical Affairs, Regulatory, Commercial).

Lead Department – Scientific Communications

Manager

• Collaborate with Clinical Development teams or CROs to meet project timelines for statistical data analysis and reporting
• Oversee or independently produce and validate programming deliverables such as analysis datasets, tables, listings, and figures
• Anticipate resource needs and coordinate with management to ensure long-term resource allocation for therapeutic projects
• Ensure quality control (QC) is performed on all derived datasets, tables, listings, and figures in alignment with company standards and regulatory requirements
• Participate in developing global programming standards to enable consistent deliverables across portfolios; create tools supporting SDTM/ADaM dataset generation and TLF production
• Provide functional expertise in establishing BioNTech’s centralized clinical data repository, clinical data dictionary, and operational data dictionary
• Collaborate with Biostatistics to develop statistical applications such as data review and reporting tools
• Support regulatory submissions by preparing data submission packages including define.xml

Senior Manager, Statistical Programming

Clinical Operations

• Lead the strategy, prioritization, and management of BioNTech’s global external research portfolio across IIS, CRS, Phase IV/PASS programs.
• Collaborate with Medical Affairs, Clinical Development, Market Access, and Commercial teams to define and execute a multi-year cross-indication external research strategy.
• Establish global standards for external research processes and governance while driving harmonization across regions.
• Ensure efficient and compliant execution of external research programs by leading cross-functional project teams.
• Develop robust financial frameworks for forecasting, milestone payments, and resource utilization aligned with corporate priorities.
• Drive strategic initiatives such as improving governance models and building data/RWE platforms.