Compensation: $115,110.00 - $148,640.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
Principal Scientist of Pharmacology will serve as the pharmacology lead on a number of 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.
You will also work in close collaboration with scientists in Translational Research and Clinical Development to conduct quantitative PK/PD/safety/efficacy analyses for integration into overall program strategies. You will provide rationale for dose regimen selection in FIH trials and beyond, and identification of circumstances where dose adjustment or patient selection/stratification should be considered. You will be responsible for all aspects of quantitative modeling & simulation strategies for candidate drug products from early development (pre-IND) through late stage development using model-based approaches to improve the efficiency of drug development, improve our mechanistic understanding and support dose selection.
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.
Provides pharmacology support on multi-disciplinary study teams for pre-clinical and clinical programs
* Contributes expert pharmacology input into key pre-clinical, clinical and regulatory documents including study protocols, study reports, investigator brochures, and other documents within agreed timelines
* Develops PK/PD modeling and simulation plans to guide rational first in human dose projection and dose selection
* Leads clinical pharmacology 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. Analyzes results, interprets, and recommends action based on study results.
* Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.
* Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.
* 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
* Coordinate with clinical and translational medicine teams on strategic priorities and study support
* Performs other responsibilities as requested by management
Skills & Experience
A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline with at least 3 years of experience in Clinical Pharmacology and/or pre-clinical PK is required
* 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 also required
* Demonstrated ability and experience in apply modeling and simulation approaches to enable rational and efficient preclinical and clinical drug development are required
* Proficiency of the application of a broad range of quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, R and other PK/PD analysis software.
* Extensive experience and strong understanding of oncology drug development is preferred
* Flexible, with positive 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
* Domestic and international travel will be required.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
Genmab has selected Korn Ferry as a global recruitment partner to help us manage your application.
Associated topics: antibody, aseptic technique, drug development, health, immunoassay, microbiological, pharmacy, physiology, therapy, transfection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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