Companion Diagnostics Lead
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
In this position, you will be part of the broader global Translational Research team, leading all diagnostic (Companion and Complementary Dx) efforts for the Genmab portfolio. You will provide diagnostic strategy and expertise in building the Diagnostics department within Genmab, while simultaneously leading one to two diagnostic projects for the Genmab portfolio. You will ensure the execution of CoDx strategy for appropriate clinical programs, while working closely with the other functional units involved in clinical development (operations, clinical, biomarkers, regulatory, safety, etc). You will also work closely with commercial and medical affairs teams on longer life cycle plans for any joint therapeutic/diagnostic product(s). You will also help craft and deliver the future state of Genmab’s diagnostic strategy, including a heavy focus on personalized and tailored therapeutics.
- Leads Companion Diagnostic efforts for Genmab portfolio, including one program with an immediate companion/complementary diagnostic project
- Develop the broader Diagnostics Department strategy for Genmab, together with senior leaders in clinical, translational research, commercial, medical affairs, and regulatory
- Build the Diagnostic Department and area of expertise for Genmab, including organization of the team, talent identification and recruitment
- Manage the Diagnostic Department within Genmab, including managing the Dx budgets, team structure, and work flows that fit into the broader clinical projects and portfolio
- Provide oversight, guidance, expertise, project management, and regulatory expertise for companion diagnostic projects within Genmab’s portfolio, working closely with other functional units and/or external contractors as needed to execute on CoDx project
- Help guide early development decisions by providing forward thinking on assay development, regulatory strategy, commercial diagnostic strategy, and the potential diagnostic partners based on the current diagnostic space and the project goals.
- Help map diagnostic partner options and the strategic considerations in choosing a diagnostic partner for projects
- Help drive and execute/deliver on diagnostic strategies that are agreed upon within specific project teams
- Provide expert knowledge on regulatory requirements for the validation of biomarkers, development of companion diagnostics, and devices, globally - especially in the US, Europe, and Japan.
- Help develop diagnostic strategies that fit into the broader project teams, including timelines, diagnostic partnership, budget, responsibilities, and resources (budget/FTEs)
Skills & Experience
- You have an advanced degree (PhD, MD, DVM) and at least five years of experience in leading companion diagnostic projects.
- You have a track-record of successfully managed CoDx projects and success in working with multiple cross-functional teams.
- You are capable of directing and managing research at CRO’s or external vendors, and able to take decisive actions.
- You have solid experience with regulatory processes and diagnostic/LDT guidelines as well as with GLP, GCP, and other quality systems for the pharmaceutical drug development process.
- You have a positive, open, and objective mind-set but also have critical thinking skills.
- You are willing to work on active projects, but also have a vision for a future where Genmab diagnostics helps match patients to the appropriate therapy.
If you are interested in the position, please apply via https://genmab.loop.jobs/job/Genmab-Princeton-New-Jersey/62300697