Senior Director/Business Partner - R&D Digital, Data & Informatics (Regulatory Affairs)
Senior Director/Business Partner - R&D Digital, Data & Informatics (Regulatory Affairs )
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
In this Senior Director role, you will:
- Own R&D Digital relationship with Regulatory Affairs and be accountable for business outcomes enabled by technology and digital
- Act as primary contact for Regulatory Affairs to manage and prioritize customer demands across the end-to-end lifecycle of development technology services
- Provide strategic technology partnership to Regulatory Affairs and help shape and drive growth, innovation, and differentiation
- Conduct ongoing horizon-scanning for relevant industry trends and assess potential implications for Regulatory affairs
- Act as an advisor to identify and deliver relevant value-add solutions
- Translate functional business requirements for Digital, Data & Informatics and Core IT teams
- Ensure implementation of fit-for-purpose regulatory systems through co-ordination of system integrators and vendors
- Support Regulatory Affairs in identifying local process requirements and ensures that systems support these processes
- Engage key stakeholders to communicate progress on Digital, Data & Informatics initiatives
- Ensure RIMS/DMS solutions are compliant and support technical activities e.g., system audits
What you have to offer.
- Bachelor's degree in Computer Science, Mathematics, Information Systems, Medical, or Biomedical sciences
- 5+ years’ extensive experience in managing Regulatory Affairs, or Clinical applications and data analytical systems
- Experience managing Clinical Development/Trial execution programs preferable
- Experience from mid-size biotechnology or pharmaceutical organization preferable
- Experience engaging with regulatory agencies (e.g., FDA, EMA) preferable
- R&D Digital expert, with strong focus on Regulatory Affairs or Regulatory Affairs expert, with deep ‘user’ understanding of system
- Deep business domain knowledge of Regulatory Affairs preferably for the US and EU
- Ability to collect and understand Regulatory Affairs business requirements from cross functional stakeholders to ensure solutions are delivered to business on time and budget
- Good understanding of Clinical systems & RIMS/DMS/IDMP
- Good knowledge of information management, data quality, data constraints and Governance frameworks
- Experience in managing external service providers and suppliers
- Passion for optimizing the customer / end-user experience
- Excellent interpersonal, verbal, and written communications skills
- Exhibits a high degree of self-awareness, empathy, listening, and active curiosity
- High ability to work under pressure and adjust quickly
- Nurtures and develops a collaborative, consultative & value driven partnership
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and subsidized parking
- Discounted Home and Auto Insurance
- Pet Insurance
- And more!
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 5215 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you