TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company
Transcenta, biologics, antibody
•Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program and robust registration packages
•Play a central role in predicting human dose range, characterizing dose-response relationship and justifying dose recommendations for special populations
•Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
•Develop mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance
•Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the special populations on PK where appropriate
•Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
•Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators
•Innovate through working effectively with colleagues in the department and other matrix team members, including: statisticians, biologists, toxicologists and bioanalytical scientists
•Learn and apply emerging modeling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality
•Promote clinical pharmacology strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences Function as an internal expert in oncology and inflammation/immunology translational medicine. Educate/coach other team members through knowledge sharing. Present and report data in external meetings and publications.
Ph.D. or MD. Experience using modelling tools for quantitative clinical pharmacology such as NONMEM, WINNONLIN, Simcyp, or MATLAB. Experience working with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs.
Understanding of pharmacokinetic and pharmacodynamic principles; knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancer and other relevant therapy areas.
Effectively work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic