Associate Director, Clinical Pharmacology and Quantitative Science, DMPK

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

You will serve as the Drug Metabolism and Pharmacokinetic (DMPK) expert on development programs that include characterization and prediction of absorption, distribution, metabolism, and excretion (ADME) properties of small molecules, antibody drug conjugates (ADC) and biologic discovery projects. You will provide deep scientific expertise and strong strategic input on DMPK aspects, including but not limited to in vitro and in vivo ADME, bioanalysis, animal PK, toxicokinetic, drug metabolism, transporter based DDI, human PK predictions, PK/PD modeling and PBPK. You will be responsible for devising strategies and implementing experiments to understand drug disposition mechanisms and PK-PD relationships from preclinical to clinical setting. You may also serve as the pharmacology lead on several pre-clinical and clinical development programs, providing pharmacology support and execution of clinical development plans that include characterization and prediction of pharmacokinetics and pharmacodynamics of the drug candidate.

This is an exciting opportunity to be part of a passionate, high profile, high-impact Pharmacology team, and work in a highly dynamic and collaborative setting.

The level of the role will be commensurate with the individual's level of experience.

Responsibilities:

• Responsible for ADME characterization and ADME related development activities

• Provides DMPK support on multi-disciplinary study teams for pre-clinical and clinical programs

• Accountable for ensuring appropriate design and implementation of ADME experiments in collaboration with bioanalytical group

• Contribute to in vitro DDI and other in vitro/in vivo DMPK assessment for individual preclinical drug candidates and ensure timely availability of key data as part of the IND enabling activities

• Contribute to outsourcing of DMPK studies and ensure timely and high-quality conduct of in vitro and in vivo ADME studies

• Contributes expert input into key pre-clinical, clinical, and regulatory documents including study protocols, study reports, investigator brochures, and other documents within agreed timelines

• Performs or oversees DMPK analyses using a variety of tools and approaches. Integrates, interprets, and reports data to project teams

• Works with clinical pharmacology leads to support efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions

• Serve on Global Clinical and Pre-Clinical Development Teams as Pharmacology representative and provides a source of Pharmacology expertise and advice to other functions across the Company as needed

• Collaborate with the Clinical Pharmacology representative on Global Clinical and Pre-Clinical Development Teams and provides a source of DMPK expertise and advice to other functions across the Company

• Coordinate with clinical and translational medicine teams on strategic priorities and study support

• Stay up to date with the scientific advance and regulatory landscape for DMPK science in drug discovery and development

• Performs other responsibilities as requested by management

Requirements:

• A Pharm D or PhD in pharmaceutical science, chemistry, drug metabolism, pharmacokinetics, pharmacology, clinical Pharmacology, or related discipline with at least 5 years of experience in DMPK in the pharmaceutical industry or CRO is required

• Experience in ADC drug development is highly desirable

• Broad understanding of ADME and in vitro drug metabolizing enzyme and transporter assays

• Experience utilizing DMPK knowledge into broader project team to help guide project decisions

• General knowledge of biotransformation and physical organic chemistry

• Understanding of bioanalytical methods and assays

• Knowledge of relevant regulatory guidance in areas such as drug-drug interaction, bioanalysis, and GLP

• Experience with PK/PD, allometric scaling, analysis and translational modeling of preclinical PK/PD data, and mechanism-based PK/PD systems using preclinical and/ or clinical data with biologics therapeutics is highly desirable

• Proficiency of the application of a broad range of quantitative tools such as WinNonLin, Phoenix, SimCYP, NONMEM, R and other PK/PD analysis software is highly desirable

• Extensive experience and strong understanding of oncology drug development is preferred

• Flexible, with positive attitude, ability to collaborate with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company

• Excellent written, verbal, and interpersonal communication skills

• Domestic and international travel will be required