|Position||Director of Clinical Pharmacology - Legend Biotech||Release Time||2019.09.23|
The role will serve as the pharmacology lead on a number of 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 individual 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. This person 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. The person 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.
1. 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
2. Develops PK/PD modeling and simulation plans to guide rational first in human dose projection and dose selection
3. 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.
4. Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.
5. 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.
6. 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
7. Coordinate with clinical and translational medicine teams on strategic priorities and study support
8. Performs other responsibilities as requested by management
9. Provide pharmacology expertise to due diligence activities as needed.
1. 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
2. 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
3. Demonstrated ability and experience in apply modeling and simulation approaches to enable rational and efficient preclinical and clinical drug development are required
4. 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.
5. Extensive experience and strong understanding of oncology drug development is preferred
o Flexible, with positive attitude, ability to work with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company
6. Excellent written, verbal and interpersonal communication skills
7. Domestic and international travel will be required.