BioNTech SE

Director

• Provide strong governance and oversight of Quality & Compliance activities across the US region
• Review and ensure effective execution of regulatory commitments
• Identify risks and gaps in local quality systems and implement proactive mitigation strategies
• Drive increased transparency, consistency, and accountability in quality processes
• Define, track, and analyze key quality metrics and performance indicators
• Deliver regular updates on regional performance, risks, and escalations to Global Quality leadership
• Ensure timely escalation and resolution of critical compliance issues
• Act as the primary point of contact for cross-functional stakeholders (Regulatory, Medical, Supply Chain, Commercial) within the region
• Foster strong collaboration to ensure aligned and compliant execution of activities
• Provide quality leadership and strategic guidance to regional and functional teams
• Lead regional Quality teams in a matrix environment, driving alignment and performance without direct authority
• Facilitate regular governance and follow-up meetings to track progress and address key challenges
• Build capability and strengthen accountability across the regional network
• Serve as a key interface with Health Authorities, including the FDA
• Support and lead inspection readiness activities and regulatory interactions
• Represent Regional Quality during inspections and audits in partnership with Global Quality
• Ensure quality readiness for product launches in the US and broader region
• Apply lessons learned to improve execution and prevent recurring issues
• Support preparation of emerging markets (America) for future launches

Director, Global Quality

Business Development Rep

• Assist a member(s) of the team in cross-functional projects among Business Alliances, Legal, Intellectual Property, and/or Research & Development
• Coordination of contractual obligations related to multi-partner, multi-asset clinical trial combination strategies
• Identifying and helping implement a fit-for-purpose Alliance Health Check platform
• Supporting the development of an alliance management and collaborations playbook
• Contributing to other business alliance initiatives, as assigned, based on the candidate’s education and/or experience.

Intern, Business Development – Alliance Management

Administrative Assistant

• Provide administrative and coordination support to the Global Product Strategy oncology team and related commercial teams, enabling efficient planning, documentation and communication across projects and meetings.
• Manage complex calendars, meeting scheduling, correspondence, filing and logistical arrangements, while ensuring activities are handled in line with company policies.
• Plan and organize internal meetings and workshops, prepare agendas and materials, coordinate attendees, take minutes, track action items and ensure timely follow up.
• Arrange detailed domestic and international travel itineraries, handle travel logistics, and process expense reports with meticulous attention to accuracy and compliance.
• Support project leads with basic project coordination, tracking timelines and deliverables, maintaining project documentation and facilitating information flow within oncology teams.
• Maintain shared drives, databases and tracking tools, ensure accurate records, support onboarding and access requests, and serve as point of contact for administrative systems queries.
• Partner with cross-functional stakeholders across Global Commercial Strategy, Finance, Procurement, Project Management, Medical Affairs, Legal, Compliance, Senior Leadership, and other internal support functions.
• Organize and coordinate off-site meetings, conferences, and company-wide events, handling all aspects of logistics, materials preparation, and post-event follow-up to ensure successful execution.

Senior Administrative Assistant

Communications

• Lead the development and execution of the integrated scientific communications strategy for assigned oncology asset(s) or franchise(s)
• Define the overarching scientific communication priorities across key milestones, including data readouts, congresses, publication milestones, regulatory events, and launch preparations
• Serve as the primary architect of the scientific narrative and messaging platform for the asset or disease area
• Maintain awareness of the external oncology landscape, including competitor data, treatment paradigm shifts, congress activity, and emerging scientific trends
• Drive communication preparedness for major data disclosures, including pre-, during-, and post-congress communication needs

Scientific Communications Leader

• Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered
• Represent external/global QC in multidisciplinary project team and define QC project strategy in related projects
• Oversees the stability program of late development projects. Ensures that stability programs are implemented and adhered to and that results are reported and evaluated.
• Oversee QC activities at CDMOs and ensure delivery of QC-associated work packages (data evaluation, deviation/OOS-investigations, CoA generation and release) in time and quality
• Act as link between global External QC Network team and Chinese CMOs
• Participate in generation and approval of QC-related GMP-documentation
• Management of full QC-value chain for relevant projects/products

Associate Director, External QC Network – China

Recruitment

• Collaborates with both US and Global leadership members and human resources business partners to identify, assess and lead the search for extraordinary talent through conventional and if required unconventional means while ensuring a positive candidate experience.
• Develop recruiting strategies to include but not limited to posting positions, selecting social media platforms, employer branding campaigns, screening applications and leading the assessment of qualified candidates.
• Schedules interviews; oversees preparation of interview questions and other hiring and selection materials.
• Assists with the interview process, attending and conducting interviews with managers, directors, and other stakeholders. Attend career events as needed.
• Collaborate with the hiring manager and/or other human resource staff during the offer process, identifying and recommending salary ranges, incentives, start dates, and other pertinent details.
• Proactively build talent pipelines through referral generation, online sourcing, events, and sourcing campaigns for key roles and identified areas of focus. Serve as a subject matter expert to the recruiting team, hiring managers, and organizational leaders on integrating effective candidate identification methods across all markets.

Senior Manager, Talent Acquisition

• Serve as the principal expert and strategic leader for medical review processes, ensuring the accurate and compliant evaluation of promotional and non-promotional materials, scientific content, and communications.
• Establish priorities that align with regulatory requirements, ethical standards, and BioNTech’s commitment to scientific excellence.
• Design, implement, and continuously refine robust medical review frameworks and SOPs.
• Lead the transformation of legacy systems into streamlined scalable processes that support BioNTech’s innovative pipeline and compliance needs.
• Build and manage agile, cross-functional workstreams to support medical review and information activities.
• Inspire, mentor, and empower a high-performing, matrixed team of medical reviewers, information specialists, and project managers.
• Act as a strategic partner to Regulatory, Legal, Compliance, Commercial, and Scientific Affairs teams, ensuring seamless communication and alignment on pipeline and marketed product strategies.
• Lead the development and delivery of scientifically accurate, high-quality medical information to healthcare professionals, patients, and internal teams.
• Stay ahead of evolving regulations, guidance, and industry standards. Lead audit readiness and risk mitigation efforts to ensure compliance and operational excellence.
• Establish and monitor key performance indicators to measure the impact and effectiveness of medical review and information services.

Director, US Medical Information – Medical Review

Product Manager

• Define and own the strategic vision for IAM and PAM platforms (e.g., SailPoint IIQ, CyberArk), ensuring alignment with BioNTech’s security goals
• Serve as the primary decision maker for all IAM/PAM initiatives, including application onboarding, process changes, and product replacements
• Evaluate platform capabilities and prioritize improvements based on business needs, compliance requirements, and emerging trends
• Oversee external service providers to ensure incidents and operational tasks meet agreed service levels and quality standards
• Make operational decisions such as patch approvals and incident prioritization to maintain system reliability and compliance
• Continuously improve IAM/PAM processes, including user provisioning, privileged account monitoring, and lifecycle management
• Collaborate across IT, security, and business teams to ensure solutions meet organizational objectives
• Provide regular performance insights to leadership and identify risks and opportunities

Associate Director – Product Owner, IAM, PAM

• Support the oncology therapeutic area by providing medical safety expertise to study management teams
• Ensure patient safety throughout the clinical trial process
• Contribute to clinical trial protocols and safety data assessment
• Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting requirements
• Train and mentor Safety Physicians and Safety Scientists

Director, Safety Physician

• 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

Associate Director, Global Labeling Lead

• Develop and execute Global value evidence generation plans for systematic literature reviews (SLR), indirect treatment comparisons (ITC), cost-effectiveness analyses (CEA), budget impact analyses (BIA), real-world evidence (RWE), and patient-reported outcomes (PRO) to optimize clinical development decisions across all stages of drug development
• Conduct global epidemiology literature reviews to inform multi-regional clinical trial site selection and recruitment strategies
• Provide guidance on FDA regulations related to patient-reported outcomes (PROs) and patient-focused drug development (PFDD), ensuring alignment with labeling claims
• Prepare regulatory-grade documents such as FDA/Global Regulatory briefing books for PRO Endpoint implementation, epidemiology, and pediatric investigation plans
• Lead the implementation of robust evidence synthesis strategies to support global pharmaceutical launches and reimbursement dossiers across HTA markets & Non HTA Markets like PICOS Simulation/Scoping, PICOS feasibility assessment and development JCA dossiers
• Lead the development of early advice (EA) dossiers (Country level and JSC) and actively participate in discussion with relevant stakeholders on the value of the clinical program
• Stay at the forefront of industry trends and integrate emerging methodologies into evidence synthesis plans including the use of AI in SLR/ITCs/ RWE and Global Value Evidence tool kit development
• Collaborate with key opinion leaders, including medical experts, through structured engagements like advisory boards and Delphi panels
• Develop pre-approval dossiers, launch models (CEA/BIA), tools, relevant Health Care Economic Information (HCEI) training materials to support US Account Management teams, Medical Science Liaisons, and field-based HEOR professionals
• Support other HEOR team members by reviewing their evidence generation plans, publications and offering constructive- solution oriented feedback
• Mentor HEOR fellows and early-career team members while providing constructive feedback on evidence generation plans

Director, Health Economics – Outcomes Research (HEOR)

• Responsible for audits within the APAC region.
• Ensuring audit objectives and scopes are risk based in alignment with the audit strategy.
• Coordinate and oversee audits performed by contracted auditors.
• This involves scheduling audits, selecting resources, reviewing reports, etc.
• Execution of the audit (remote or on site) as the lead auditor when the audit is not contracted.
• Ensure audit documentation and audit quality management system is completed according to procedures and established timelines.
• Act as a liaison to internal BioNTech stakeholders through all phases of the audit.
• Ensure that newly identified risks are considered for the audit strategy.
• Support development of a robust CAPA (Corrective and Preventative Action) Plan and approve the CAPA plan.
• Track CAPA and effectiveness checks to completion.