Associate Director, Clinical Research Scientist

At Genmab we are dedicated to building extranotordinary 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 Role

This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including clinical trial implementation and oversight of all aspects of clinical development) working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables

Responsibilities
Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds
Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (i.e. protocol ICF IB safety updates study reports regulatory submissions etc.) to support registration and commercialization of the compound(s)
Contributes in the development of case report forms (eCRFs) eCRFs completion guidelines and provide scientific support for other key data management deliverables (e.g. database lock activities).
Lead the development of medical data review plan (MDRP) perform ongoing data review and summarize efficacy and safety data for interpretation/analysis
Provide medical input for country/site selection feasibility assessment and engage in KOL interaction
Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e. Dose Escalation DMC Steering Committee Safety)
Participate in the development and review of study plans and serve as a liaison to project teams and CROs
Prepare presentations for Investigator meetings CRO/CRA training SIVs as warranted
Provide input for the development of publications in coordination with Scientific Communications
Perform training at Investigator meetings CRO/CRA training SIVs as warranted

Requirements
PhD Pharm D MS or equivalent degree preferably within the medical biological pharmaceutical science or related discipline
Minimum of 8 years of experience in clinical research with at least 4 or more years of drug development experience
Prior oncology/hematology drug development experience is a plus
Proven skills from working in a project oriented matrixed team environment
Excellent oral written and interpersonal (communication) skills
Ability to travel as needed

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can 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 maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs 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 international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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