Swedish Orphan Biovitrum

Overview In this role you drive and represent the nephrology clinical development strategy across the product lifecycle, from concept to global approvals and market access. You lead the Medicine Development Team and coordinate with the Core Asset Team, ensuring robust benefit-risk evaluation and safety oversight. You communicate with internal leaders and external stakeholders to align on plans, regulatory strategy, and data-driven decisions. This position offers impact across a global portfolio and a chance to shape treatment options for patients with rare kidney diseases.

Verantwortungsbereiche Define and drive the nephrology development strategy across life cycle, from proof-of-concept to global approvals and market access Provide clinical/scientific input to set asset strategy and optimize project success Collaborate to develop Integrated Project Plans (IPPs) with TA heads and CAT Leaders Identify program risks across functions and design mitigation plans Present the nephrology program to internal and external stakeholders; engage Key Opinion Leaders as needed Lead the Medicine Development Team (MDT) and guide cross-functional members in clinical development, safety, regulatory, and data management Ensure high-quality, consistent clinical documents (e.g., Clinical Development Plans, Protocols, Investigator’s Brochures, Clinical Study Reports) aligned with IPP and Target Product Profile Contribute to regulatory submission input and market access

documents (CDS, PSURs, benefit-risk assessments) Collaborate with Regulatory to define international submission strategies Support governance activities and maintain endorsements from Sobi governance bodies Zentrale Anforderungen Medical degree with 10+ years in academic and/or pharmaceutical GxD roles Strong track record in drug development, preferably nephrology Extensive knowledge of clinical trial methodology, global regulatory requirements, and study design/execution Advanced understanding of trial operations, including budget and timeline management Proven ability to build and execute strategic/tactical plans Experience engaging with internal/external stakeholders Specialty in nephrology with at least 5 years clinical experience and interactions with Health Authorities leading to approvals Strong leadership to lead cross-functional matrix teams Ability to coach, mentor, and

communicate effectively with diverse audiences Excellent organizational skills and proactive implementation of best practices Ability to evaluate medical/scientific literature Fluent English writing and speaking Alignment with Sobi values: Care, Ambition, Urgency, Ownership, Partnership leadership in a matrix environment clear communication stakeholder engagement clinical trial design and execution regulatory submissions and health authority interactions risk management and pharmacovigilance