Senior/ Executive Medical Director, Medical Lead IAI, Early Clinical Development

ph3Overview /h3 pIncyte is a global, science-driven biopharmaceutical company recognized for its strong growth and deep commitment to advancing therapies in Hematology, Oncology, and Immunology. /p pWith a diverse and expanding early pipeline, Incyte is shaping the next generation of targeted and immune-based therapies. Our strength lies in our ability to combine scientific insight with clinical execution, transforming discoveries into impactful medicines for patients worldwide. /p pWe are a company in motion, growing, evolving, and investing in early development as a core engine of innovation. At Incyte, every idea begins with science — and every scientist plays a part in shaping what comes next. /p h3The Role /h3 pThis position is responsible for implementing early clinical development efforts for Incyte's Dermatology, Immunology, Rheumatology products (preclinical candidate nomination through transition to registrational studies). /p h3Duties and Responsibilities /h3 ul liLeads development efforts for assets post-candidate selection through first in human trials, including early dose escalation, ph 1-2a translational strategy (proof of mechanism studies) and proof of concept studies in human (ph 1b or 2a). /li liParticipates 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. /li liProvides medical and scientific expertise for internal cross-functional team members for development of specific, dermatology and immunology agents including discovery scientists, clinical scientists, biostatisticians, pharmacokinetics, pharmacovigilance, and clinical operations. /li liSupports 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. /li liFacilitates 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. /li liCollaborates with external vendors such as CROs, external imaging and laboratory vendors for successful implementation and conduct of early phase clinical studies. /li liRepresents Incyte Corporation at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders. /li liDetects and analyzes emergent issues during early clinical drug development and develops and implements mitigating strategies. /li liWorks in partnership with medical affairs and commercial organization for successful launch of future agents. /li liImplements the highest ethical and regulatory standards during the investigation and development of anticancer agents. /li liProvides guidance for successful implementation and accomplishment of investigator-initiated trials related to product development and life cycle management of a compound. /li liActs as subject matter expert for business development activities. /li /ul h3Requirements /h3 ul liMD, MD-PhD (or PhD with 8-year clinical development experience in immunology or dermatology). For MDs a dermatology, rheumatology or clinical immunology/allergy board certification is preferred. /li liTraining 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 human. /li liProficient in English, oral and written. Member of at least one professional society (e.g. SID, ACR, AAAAI). Strives for continued medical education in immunology related area. /li liAbility to lead sub-teams and drive projects. /li liTrack record of business development and due diligence team support. /li liProven 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. /li liDesirable preferred behaviour: active listening, higher than average social sensitivity, empathy, willingness to mentor and coach. /li /ul /p #J-18808-Ljbffr