Associate Director, Clinical Pharmacology and Quantitative Science, DMPK
- Princeton, New Jersey (US)
- competitive package
- Closing date
- Jun 26, 2023
- Full Time
- PHD, PhD in Computational Biology, Biostatistics, Bioinformatics
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.
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.
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
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
Be part of the extra[not]ordinary™
Are you caring, candid, impact-driven and determined to make a difference? Join our unstoppable team as we improve the lives of patients through innovative and differentiated antibody therapeutics.
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
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