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 Medical Director Global Risk Management & Safety Surveillance GRMSS is responsible for developing and ensuring execution of all patient safety risk management activities for molecular entities under clinical development as well for Incyte marketed products. This will include pharmacovigilance and risk management activities and interventions designed to identify characterize prevent or minimize risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions. The position will require strong oversight for patient safety issues that arise at both the individual and aggregate levels within the company and in collaboration with co-development and business partners strong decision-making skills on all issues involving safety assessment and surveillance responsibility for compliant timely and complete regulatory authority engagement with particular emphasis on benefit-risk assessments and risk identificationcharacterization and mitigationmanagement and effective communication of safety information to internal and external stakeholders. The position will need to effectively lead teams and engage cross-functionally. The Executive Medical Director reports to the Head of Global Pharmacovigilance and Risk Management. Essential Functions of the Job Key responsibilities Lead the Safety Management Team and direct all safety risk management activities for assigned products. Lead other teams as required. Ensure local and global risk management plan preparation and execution throughout a medicinal products lifecycle. Formulate clinical trial and postmarketing risk management safety strategies that are in alignment with the companys drug development and commercialization strategies. Perform drug safety signal detection activities for Incytes portfolio of investigational and marketed products develop medically reasonable evaluations of safety signals and make specific actionable and defensible recommendations for confirmation or refutation of safety signals. Manage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance. Provide secondary medical review of ICSRs for designated products as necessary as well as back-up when primary medical reviewer is not available and provide follow-up guidance for specific safety topics to Case Operations team or PhV vendor as appropriate to ensure consistent high-quality reports Review emerging literature regarding Incyte products as well as relevant products from collaboration partners to identify new and important information that potentially impact human safety conduct reviews both independently within Incyte and in conjunction with external collaboration partners. Drive preparation of IND Annual Reports andor DSURs for Incyte clinical trial programs and PADERs andor PSURPBRERs for marketed products. Perform Health Hazard Evaluations. Participate significantly in the strategic planning development and production of integrated summaries of safety summaries of clinical safety clinical overviews and other registration documents for new and supplemental NDAsBLAs andor ex-US new drug submissionsvariations for late-phase drug development candidates and marketed products in conjunction with Clinical Development Medical Writing Statistics and Regulatory Affairs. Drive the safety strategy for Reference Safety Information for Incyte products including Investigator Brochures and new or updated labeling USPI SmPC or CDS for marketed products in the context of multidisciplinary groups within Incyte or joint committees between external partners. Participate in internal safety process improvements and updates including new means of effective presentation of early phase clinical study status reports with regard to safety findings. Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance and contribute to the development and implementation of any preventative andor corrective action plans as they pertain to specific identified deficiencies of policy procedure or practice in GRMSS. Review medical and safety content included in standard response letters prepared by Medical Affairs as necessary and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information. Champion risk management safety strategy to internal eg Clinical Development Medical Affairs Regulatory Affairs Quality Assurance Commercial Translational & Experimental Medicine and Legal and external eg regulators and commercial collaborators stakeholders. Serve as the GRMSS medical representative for joint clinical development programs with external partners as required. In the absence of the EUUK QPPV the GRMSS physician or their back-up is responsible for responding to product-related queries as delegated by the EUUK QPPV. Qualifications M.D. or international equivalent. Minimum of 10 years of experience in pharmaceuticalbiotechnology industry or regulatory agency of which more than 5 years will have been in a pharmacovigilance or risk management role. In-depth knowledge of USEU risk managementGVP landscape. First-hand experience interacting with regulators with risk management issues. Experience as an active contributor with drug registrations Clinical Study Reports Integrated Summaries of Safety Summaries of Clinical Safety and Clinical Overviews. Strong interpersonal and people management skills experience effectively leading teams. Strong collaboration skills and ability to engage cross functionally. Preferable but not an absolute requirement M.P.H. or relevant epidemiology experience in industry or academia. Board certification in internal medicine or pediatrics primary care or hematologyoncology specialty. Experience in pharmaceutical industry activities outside the United States. Experience in clinical trial development and execution. Training or experience in oncologic or inflammatory diseases or relating to clinical safety support of oncology immunomodulatory or other related products. 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