Digital Product Manager Clinical Development
4 weeks ago
Genmab is seeking a highly skilled Digital Product Manager to join our Clinical Development team. As a Digital Product Manager, you will be responsible for overseeing the product strategy, development, and implementation of technology products in different focus areas in Development Operations. This includes Trial Management, Trial Monitoring, Clinical Data Management, Trial Analytics, Stats Programming, and Medical Writing. You will collaborate closely with Business to help define product vision and roadmaps based on business requirements and user needs.
Key Responsibilities- Using the Product Oriented Delivery (POD) model, ensure its success and application in the development/implementation and utilization of technology products across the Development Operations value chain.
- Be accountable for the full life cycle of products in your portfolio from concept to retirement.
- Collaborate with Business and IT&D stakeholders and SMEs to define product vision and roadmap aligning with organizational goals.
- Drive the design, development/implementation, testing, deployment, and ongoing product evolution and SLA-based operational support of high-quality products.
- 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, addressing any issues affecting quality or user satisfaction, and optimize processes for improved efficiency.
- Bachelor's degree in Computer Science, Engineering, Lifesciences. MBA or Master's degree in strategy, management, engineering, or a related field preferred.
- In-depth knowledge of Agile Software Development Methodology and related tools like Jira.
- 8+ years of experience as a product owner, product manager, senior business analyst in Clinical Operations and/or Clinical Data Management & Analytics, with at least 3 years in a delivery leadership role.
- Product Lead, or similar, role in SaaS GxP implementations and/or bespoke GxP digital products in one or more focus areas: Trial Management, Trial Monitoring, Clinical Data Management, Trial Analytics, Stats Programming in a mid-sized biopharma or CRO.
- Experience working with GxP regulations and procedures around change management, periodic reviews, and internal audits.
- Knowledge of the ITIL framework and SLA-based environment.
- Experience leading RFI/RFP processes for market scan, vendor evaluation, and selection, in collaboration with Business and IT stakeholders and other cross-functional teams.
- Ability to effectively interpret a business problem into a technical solution and articulate it back to the business stakeholders.
- Solid understanding of regulatory guidelines and data standards (e.g., CDISC) is a plus.
- Ability to work with and lead diverse and cross-functional teams.
- Excellent communication, negotiation, and interpersonal skills, with the ability to engage and influence stakeholders at all levels.
- Strong problem-solving skills and the ability to work in a fast-paced, dynamic environment.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan.
We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice.
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