Senior Medical Director, Early Clinical Development

Das ist der Job

They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.

Darum lohnt es sich

ph3Overview /h3pJob Summary (Primary function) /ppThis position is responsible for implementing early clinical development efforts for Incyte's Hematology and Oncology products (preclinical candidate nomination through transition to registrational studies). /ph3Essential Functions Of The Job (Key Responsibilities) /h3ulliLeads 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). /liliParticipates 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. /liliProvides 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. /liliSupports 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. /liliFacilitates 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. /liliCollaborates with external vendors such as CROs, external imaging and laboratory vendors for successful implementation and conduct of early phase clinical studies. /liliRepresents Incyte Corporation at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders. /liliDetects and analyzes emergent issues during early clinical drug development and develops and implements mitigating strategies. /liliWorks in partnership with medical affairs and commercial organization for successful launch of future agents. /liliImplements the highest ethical and regulatory standards during the investigation and development of anticancer agents. /liliProvides guidance for successful implementation and accomplishment of investigator-initiated trials related to product development and life cycle management of a compound. /liliActs as subject matter expert for business development activities /li /ulh3Professional Competencies Business Insights /h3ulliMD, MD-PhD.

Strives for continued medical education in Hem Onc area. /liliAbility to lead sub-teams and drive projects. /liliTrack record of business development and due diligence team support /li /ulh3Behavioral Competencies /h3ulliProven record of successful work in diverse, cross-functional teams (co located or not). /liliWillingness to share and coach other Incyte employees within ED and beyond. /liliDesirable preferred behavior: active listening, higher than average social sensitivity, empathy, willingness to mentor and coach. /li /ulpDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.

Hematology-oncology board certification is preferred. /liliTraining 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. /liliProficient in English, oral and written. /liliMember of at least one professional society (ASH, ASCO, AACR, ESMO).

Management reserves the right to change or modify such duties as required. /ppWe Respect Your Privacy /ppLearn more at: /ppThe Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. /ppDuring 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 here. /ppYou may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.

You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. /ppYou can learn more about Incyte’s data protection practices here.

By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). /ppPlease contact if you have any questions or concerns or would like to exercise your rights. /ph3Seniority level /h3ulliDirector /li /ulh3Employment type /h3ulliFull-time /li /ulh3Job function /h3ulliResearch /liliIndustries /liliPharmaceutical Manufacturing /li /ul /p #J-18808-Ljbffr