Senior Medical Director, Early Clinical Development

Darum lohnt es sich

Provides medical and scientific expertise for internal cross-functional team members for development of specific, hematology-oncology agents including discovery scientists, clinical scientists, biostatisticians, pharmacokinetics, pharmacovigilance, and clinical operations.

Overview Job Summary (Primary function) This position is responsible for implementing early clinical development efforts for Incyte\'s Hematology and Oncology products (preclinical candidate nomination through transition to registrational studies).

Essential Functions Of The Job (Key Responsibilities) Leads development efforts for assets post-candidate selection through first in human trials, including early dose escalation, safety and tolerability evaluation, dose selection, translational medicine (proof of mechanism studies) and proof of concept studies in human (ph 1 or 2).

Participates in asset/portfolio strategies and prioritization, internal and external messaging, governance, and cross-functional interface with all key stakeholders, including translational science, clinical pharmacology and pharmacometrics, discovery organization, regulatory and others.

Supports interactions with global regulatory bodies including the FDA, EMA, PMDA and TGA and ethics committees to accomplish tasks related to product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and other regulatory documents.