Associate Director - Evidence Generation

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department
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.

Key Responsibilities Include

• Oversee successful implementation of 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.
• Initiate, author, or contribute to SOP development, implementation, and training.
• Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals.
• Participate in process improvement exercises to drive operational excellence.
• May represent the department at cross-departmental events.

Requirements

• Bachelor's or Master's or Advanced degree in a scientific discipline.
• 8+ years of relevant experience in pharma/biotech industry, preferably in Oncology.
• Program and/or Project management experience with leading teams, study protocols or programs preferred.
• Experience managing global ISTs and/or Medical Affairs initiatives preferred.
• Therapeutic knowledge in oncology (e.g. lymphoma, breast cancer, solid tumors), pharma and biologics is a plus.
• Experience with budgeting and contracting.
• Experience producing and analyzing metrics/reports.
• High attention to detail, strong analytical and organizational skills.
• Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or independent non-clinical and clinical studies and articulate summary information in verbal and written form.
• Must have a demonstrated ability to successfully develop, implement, and manage Investigator-Driven Programs.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interactions.

This role is hybrid and based in Utrecht, The Netherlands, or Copenhagen, Denmark.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab
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 (KYSO™) 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.

Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we 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. Learn more about our commitments on our website.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Location: Copenhagen - Carl Jacobsens Vej 30

Additional location:

• Utrecht