Associate Director, Clinical Research Scientist

4 weeks ago

København V, Denmark Genmab Full time

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
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.

This position is hybrid, and can be filled in HQ, Copenhagen, Denmark, Utrecht in The Netherlands or Princeton, NJ, US.

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
Moreover, you meet the following professional 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 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 (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.

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

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
  • United States (Remote)
  • Princeton, NJ

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