Senior Scientist, Clinical Pharmacology & Quantitative Science

Genmab

  • Utrecht
  • Contract
  • Voltijds
  • 1 maand geleden
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 RoleAt 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.As our new Senior Scientist, Quantitative Translational Pharmacology, you will provide pharmacology expertise to programs through all stages of research and development, with a focus on early stage assets. You will be responsible for defining a translational modeling and simulation strategy, and leading cross-functional project teams tasked with executing this strategy, to determine the appropriate route of administration, dose levels, dosing regimens for first-in-human (FIH) clinical trials.In this role, you will generate an in-depth understanding of all aspects of PK and PD of Genmab’s current and future antibody technologies, building and refining platform quantitative system pharmacology models and applying these models to guide rational experimental designs and critical decisions on candidate antibody therapies.This is an exciting opportunity to be part of a passionate, high profile, high-impact Clinical Pharmacology & Quantitative Science team, and to work in a highly dynamic and collaborative setting, with opportunities for professional development!Responsibilities
  • Provide pharmacology support to multi-disciplinary study teams for pre-clinical programs.
  • Define and execute PK/PD modeling and simulation plans to guide rational FIH dose projection and dose selection.
  • Support FIH dose escalation, recommended phase 2 dose selection and further clinical development through continued model refinement.
  • Contribute expert pharmacology input into key pre-clinical and regulatory documents including study reports, clinical trial protocols, investigator brochures, and other documents within agreed timelines.
  • Assume responsibility for TK, PK and PD evaluation and reporting in assigned non-clinical studies.
  • Contribute to building and refining platform quantitative system pharmacology models to generate in-depth understanding of PK/PD characteristics of proprietary antibody technologies.
  • Lead pharmacology efforts (e.g., study design, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions.
  • Perform PK and PK/PD analyses using a variety of tools and approaches.
  • Analyze results, interprets, and recommends action based on study results.
  • Serve on Compound Development Teams and provides a source of pharmacology expertise and advice to other functions across Genmab.
Requirements
  • A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline is required.
  • Approximately 3-5 years of experience in pre-clinical and/or clinical pharmacology in pharma, biotechnology, or consulting is required.
  • Experience with noncompartmental PK analysis, allometric scaling, analysis of pre-clinical and/or clinical PK/PD data is also required.
  • Affinity for quantitative methods and demonstrated ability to apply modeling and simulation approaches to pre-clinical and clinical drug development are required.
  • Hands-on experience with programming in R is highly desired.
  • Experience with application of quantitative tools such as NONMEM, WinNonLin/Phoenix, and/or other PK/PD analysis software is preferred.
  • An understanding of antibody therapeutics development and experience in the field of oncology or immunology are considered beneficial.
  • Flexible, with a positive and proactive attitude, ability to work with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company.
  • Excellent written, verbal, and interpersonal communication skills.
About YouYou are genuinely passionate about our purposeYou bring precision and excellence to all that you doYou believe in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with a broad spectrum of backgroundsYou take pride in enabling the best work of others on the teamYou can grapple with the unknown and be innovativeYou 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!LocationsGenmab 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 you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.About GenmabGenmab 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, 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on and .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 contract.

Genmab