Head of Data Standards & CRF Design (all genders)

requirements

• You hold an advanced degree in Life Sciences, Data Science, Information Systems, Computer Science, or an equivalent scientific or technical discipline. • You bring 10 or more years of progressive experience in clinical data standards within a pharmaceutical, biotech, or CRO environment, including demonstrated progression into senior leadership roles. • You have at least 5 years of experience leading and developing global, multidisciplinary teams responsible for data standards definition, implementation, and cross-functional integration. • You possess deep expertise in CDISC standards and submission-related deliverables, including CDASH, SDTM, Define.xml, annotated CRF (aCRF), SDRG, and inspection-ready metadata governance. • You have proven experience in CRF design, eDC study build standards, metadata repository lifecycle management, external data standards, and regulatory submission readiness. • You demonstrate a strong track record in governance, quality oversight, risk management, vendor and CRO partnership, and cross-functional decision-making in a regulated clinical development environment. • Experience with emerging standards and technologies such as Dataset-JSON, SDTM v3.0, CDISC Open Rules, ICH M11, HL7 FHIR-to-CDISC interoperability, or AI-enabled metadata and protocol-to-CRF automation is a plus. • Strong executive communication, stakeholder influence, change leadership, and the ability to represent the function in external standards or industry forums are advantageous. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!