Job Summary (Primary function)
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.
• 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.
• 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.
• Facilitates the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, CRFs, CSRs, meeting abstracts, scientific journal publications, strategy documents and project plans.
• Collaborates with external vendors such as CROs, external imaging and laboratory vendors for successful implementation and conduct of early phase clinical studies.
• Represents Incyte Corporation at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders.
• Detects and analyzes emergent issues during early clinical drug development and develops and implements mitigating strategies.
• Works in partnership with medical affairs and commercial organization for successful launch of future agents.
• Implements the highest ethical and regulatory standards during the investigation and development of anticancer agents.
• Provides guidance for successful implementation and accomplishment of investigator-initiated trials related to product development and life cycle management of a compound.
• Acts as subject matter expert for business development activities
Job specific competencies
• MD, MD-PhD. Hematology-oncology board certification is preferred.
• Training in research (wet lab), proven track record of self-directed scientific work (e.g., post doc, peer reviewed publications as first author) preferred. Experience in early drug development required with proven track record of leading clinical pre-clinical candidate to PoC in humans.
• Proficient in English, oral and written.
• Member of at least one professional society (ASH, ASCO, AACR, ESMO). Strives for continued medical education in Hem Onc area.
• Ability to lead sub-teams and drive projects.
• Track record of business development and due diligence team support
Behavioral competencies:
• Proven record of successful work in diverse, cross-functional teams (co located or not).
• Willingness to share and coach other Incyte employees within ED and beyond.
• Desirable preferred behavior: active listening, higher than average social sensitivity, empathy, willingness to mentor and coach.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
