Job at a glance
Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. We look forward to hearing from you!
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Job Description The PV Partnership & Operations Director provides strategic leadership, accountability and effectiveness of the Sobi PV Partnership & Operations function, ensuring productive collaboration between Sobi PV Operations, internal stakeholders (including clinical development functions and clinical development teams), co-development, co-promotion and distributor partners, and external service providers (GPV and clinical development vendors).
Under the overall lead of the Head of Global PV Operations, the PV Partnership & Operations Director works together with the PV Vendor Management Director and the PV Licensing Director to ensure the overall delivery of the Sobi PV Operations function. The focus of the PV Partnerships and Operations being towards the “customers” of GPV and the ongoing maintenance and compliance of activities associated with these partners.
The role is accountable for partner-related PV operations activities, including the operationalisation and ongoing compliance with pharmacovigilance agreements, ensuring PVA commitments are adhered to from both Sobi and partners sides, and oversight of case exchange and reconciliation activities. The role is generally more focused towards product level engagements – in terms of product level Partner engagements, and product and study level development and clinical trial activities.
The role works closely with PV Licensing for the set up and implementation of PVAs, and with PV VM to direct the delivery of Sobi PV vendors. Together with GPV Safety Science and appropriate Sobi RDMA functions, this role has a strategic leadership to drive best practices for clinical trial operations, clinical trial systems and clinical trial vendor management. This includes PV delivery that is both GVP and GCP inspection ready and compliant The Director leads and develops the PV Partnership & Operations team.
This global team of “product aligned” PV Partnership Managers are responsible for the product level deliverables. The team members are located in several countries. Key Responsibilities: Functional leadership and team management Lead the PV Partnership & Operations function, assigning and coordinating activities across the team, setting strategic direction, priorities, operating model, governance structures and performance expectations.
Provide overall accountability for the function’s activities, deliverables, quality, compliance, risk management, performance monitoring and inspection readiness. Highlighting areas of concern to GPV Management Lead, develop and oversee the PV Partnership & Operations team, including resource management, recruitment, performance management, capability building, coaching, escalation support and succession planning.
Partnership governance and pharmacovigilance agreements Provide PV functional leadership for new and existing Sobi partner collaborations, including alliance leadership, operational activities, PV process alignment, governance meetings and escalation processes. Accountable for that partner and distributor obligations under PVAs and SDEAs are clearly defined, implemented and fulfilled. Accountable for case exchange elements in Pharmacovigilance Agreements and Safety Data Exchange Agreements (inc oversight and reconciliation