Executive Director, Clinical Development - Hematology Oncology

Incyte Corp

Wilmington, DE

JOB DETAILS
SKILLS
Analysis Skills, Biostatistics, Biotech and Pharmaceutical, Cancer, Candidate Screening, Case Report Form (CRF), Clinical Practices/Protocols, Clinical Research, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Processing, Documentation Plan, Drug Development, FDA (Food and Drug Administration), Hematology, Information/Data Security (InfoSec), Informed Consent, Investigational New Drug (IND), Medical Affairs, Medical Products, Multitasking, New Drug Application, Oncology, People Management, Pharmacovigilance, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Product Documentation, Product Lifecycle Management, Project Planning, Regulations, Research Protocols, Scientific Publications, Writing Skills
LOCATION
Wilmington, DE
POSTED
29 days ago

Overview A global biopharmaceutical company on a mission to Solve On Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery development and commercialization of proprietary therapeutics Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology Oncology and Inflammation and Autoimmunity Headquartered in Wilmington Delaware Incyte has operations in North America Europe and Asia. Job Summary The Executive Director Oncology Drug Development is responsible for implementing clinical drug efforts for Incytes oncology products Phase I though Phase III. Essential Functions 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 pharmacovigilance and clinical operations. 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 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 resources as well as global pharmaceutical companies for successful implementation and conduct of early phase and registration global clinical studies. Serves as a source for medical and scientific expertise in oncology for outlining design strategy and execution for anti-cancer drug development. Liaises with discovery science to facilitate and further the development of investigational agents from a preclinical stage to clinical development. 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 clinical drug development and develops and implements mitigating strategies. Works in partnership with medical affairs for successful launch of future antineoplastic 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. Qualifications Minimal acceptable level of education work experience and competency M.D. or D.O. degree with a minimum of 3 - 5 years of experience in oncology drug development in a biotechnology or pharmaceutical company. Board certified or eligible in Oncology preferred. Excellent written and oral communication skills. Ability to multi-task and work in a face paced environment. 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. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at httpwww.incyte.comprivacy-policy The 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. 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 here. You 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. You can learn more about Incytes 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 Incytes data protection officer and your supervisory authority if applicable. Please contact privacyincyte.com if you have any questions or concerns or would like to exercise your rights. LI-MB1

About the Company

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Incyte Corp