Senior Manager, Enterprise Digital Solutions - Global Drug Safety and Pharmacovigilance

Genmab•Princeton, FL

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! At Genmab, AI and Digital Technologies are being developed, implemented, and utilized at a pace never seen before. Join Genmab as part of our Enterprise Digital Solutions function and become a key player in revolutionizing antibody-based medicines for cancer and serious diseases. We are at the forefront of merging deep antibody expertise with groundbreaking scientific discovery, focused on transforming patient care. Dive into the dynamic world of AI and Digital Technologies at Genmab! Role Overview As a Senior Manager within the Enterprise Digital Solutions team, which forms an integral part of Genmab's broader Data, Digital, and AI (DD&AI) enterprise function, you will play a vital role in shaping and executing the technology product strategy for Global Drug Safety and Pharmacovigilance. Your responsibilities will encompass leading the development and implementation of technology products, as well as overseeing their ongoing enhancement, support, and maintenance. Strategic Product Management The systems and digital solutions managed in this role are essential for enabling the business to operate efficiently and manage Genmab’s expanding portfolio of drug development and marketed products. Your deep expertise in product management, especially in delivering GxP-compliant Pharmacovigilance solutions, combined with comprehensive knowledge of the business domain and processes, will be crucial to your success. Collaboration and Leadership In this position, you will work closely with business stakeholders to define product vision and roadmaps, ensuring alignment with business requirements and user needs. You will establish and lead agile delivery teams, taking responsibility for the successful delivery of projects as well as the continuous evolution and operational support of these products. Operational Excellence and Value Creation This role is central to ensuring that operations remain efficient and compliant, while also maximizing the value generated from Genmab’s platform investments. Your leadership will help drive successful outcomes and sustained value for the organization through effective platform management and support.

Requirements

Bachelor's degree in Computer Science, Engineering, Lifesciences. Master’s degree/MBA preferred.
10+ years of experience as a product owner, product manager, senior business analyst in Global Drug Safety and Pharmacovigilance domain, with at least 5 years in a leadership role leading cross functional project delivery teams of internal SMEs and external contractors/vendors
Product Lead, or similar, role in SaaS GxP implementations and/or bespoke GxP digital products in a mid-sized biopharma or CRO
Expertise with GxP regulations and procedures. Direct experience in delivery & maintenance of GxP-compliant systems and solutions.
Excellent communication, negotiation, and people skills, with the ability to engage and influence stakeholders at all levels.
Strong problem-solving and prioritization skills and the ability to work in a structured & organized manner in a fast-paced, dynamic environment.
Skilled at vendor and financial management
Experience leading RFI/RFP processes for market scan, vendor evaluation, and selection, in collaboration with Business and technical stakeholders and other enabling functions
Solid understanding of regulatory guidelines and data standards

Responsibilities

Using established SDLC and project management frameworks, drive successful development/implementation and utilization of technology products across the value chain of Global Drug Safety and Pharmacovigilance
Be accountable for full life cycle of products in your portfolio from concept to retirement. Product suite include SaaS products as well as in-house custom digital products.
Collaborate with Business and DD&AI stakeholders and SMEs to define product vision and roadmap aligned with organizational goals. Build required business cases and value propositions and align with stakeholders and leadership team
Drive the design, implementation, testing, deployment and ongoing product evolution and SLA-based operational support of high-quality products
Take ownership of driving validation deliverables to completion ensuring GxP compliance during implementation projects and beyond
Provide technical guidance and mentorship within the team, promoting a culture of collaboration, innovation, agility, and continuous improvement.
Contribute to budget planning and allocation of resources for both product development and ongoing operational support.
Track and report on product performance and user experience, addressing any issues affecting quality or user satisfaction, and optimize processes for improved efficiency.
Act as the user’s representative and voice of customer with technical SMEs.

Benefits

401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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