Associate Director, Evidence Generation

Overview

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!

The Associate Director, Evidence Generation will play a key role in executing Medical Affairs Evidence Generation projects for both approved and pipeline products. This position will be responsible for overseeing a molecule program as well as performing operational aspects of Investigator-Driven Programs:
Investigator-Sponsored trials (ISTs), Collaborative Research Trials (CRTs), Managed Access Programs (Individual and Protocol) and other initiatives within Medical Affairs.

We have a hybrid model with a requirement of working onsite in the Copenhagen, Denmark, Utrecht, the Netherlands or Princeton, NJ, USA office at least 60% of the time.

The Associate Director, Evidence Generation will execute plans with great technical depth and breadth (training & compliance, project management, medical education, grants & sponsor ships), define work instructions/process flows within own area/study, implement delivery plans and provide periodic reporting in line with overall CoE strategy (e.g. project metrics, training outcomes, grant outcomes, budgets, vendor metrics), as well as guide cross-functional and direct team members to drive compliance and address issues related to deliverables.

The incumbent will actively contribute in teams and meetings, collaborate with other medical affairs groups and external stakeholders as required, as well as train and mentor others around new technologies and scientific aspects of applied scientific research.

• Oversee successful implementation of Investigator-Driven programs
• Successfully develop, implement, and manage Investigator-Driven Programs
• Execute formal review process for proposals, protocols, and amendments
• Facilitate review committee meetings and document decisions
• Drive operational timelines and key deliverables for the program or project
• Manage proposal lifecycle from submission to study closure
• Provide guidance and oversight for the successful management of all aspects of investigator-driven programs within designated program budgets and timelines
• Partner with cross-functional teams and alliance partners to manage, adjust, and revise project timelines/budgets as necessary
• Generate regular metrics and reports of program activities and present them to leadership and strategy team as needed
• Support field-based teams and MASL teams in executing project/program goals
• Work cross-functionally with internal teams which may include development, research, legal, finance, supply chain, and regulatory
• Independently manage ISTs including site coordination, document management, and drug shipment and payments
• Contribute to contract review and negotiations
• Communicate project status and issues and ensure project team goals are met
• Represent the department at cross-departmental events, as needed
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
• Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals
• Ability to resolve problems using national and international regulations, guidelines, and investigator interactions
• Participate in process improvement exercises to drive operational excellence

• Bachelor's or Master's or Advanced degree in a…