Incyte Corporation

Summary This position is responsible for implementing clinical drug efforts for Incyte's oncology products (Phase I though POC) for oncology. Duties and Responsibilities Provides medical and scientific expertise for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilence and clinical operations Interacts with global regulatory bodies including the FDA, EMA and PMDA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) Facilitates the development of key internal and external documents pertaining to product development including clinical study protocol, investigator brochure, informed consents, CRFs, CSRs, meeting abstracts, scientific journal publications, strategy...

Summary This position is responsible for providing leadership and establishing strategy and implementing clinical drug efforts for Incyte's oncology products (Phase I though Phase III). Responsibilities Leads oncology drug development at Incyte Corporation for successful implementation and conduct of clinical trials including early phase investigations and registration trials Provides medical and scientific leadership for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilance and study delivery Interacts with global regulatory bodies including the FDA and EMA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and New Drug Applications (NDAs). Facilitates the...

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Associate Medical Director to Senior Medical Director, Oncology Drug Development is responsible for implementing clinical drug efforts for Incyte's oncology products (Phase I though Phase III). Essential Functions of the Job (Key responsibilities) Provides medical and scientific expertise for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical...

Summary The Senior Principal Biostatistician is responsible for providing statistical support to drug development programs. Responsibilities Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols. Write statistical analysis plans. Monitor internal and CRO project activities including timelines, deliverables and availability of resources. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures. Interpret study results and provide review of statistical summary reports of study results for accuracy. Assist in writing relevant sections of the clinical study report. Participate and contribute to authoring of Clinical Development Plan. Participate in pre-IND and NDA activities. Participate in the development and enforcement of SOPs and guidelines. Other responsibilities as required....