Senior Medical Director - Executive Medical Director, Global Risk Management & Safety Surveillance

Das ist der Job

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

Darum lohnt es sich

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 identification/characterization and mitigation/management); 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. /p h3Essential Functions Of The Role /h3 ul liLead the Safety Management Team and direct all safety risk management activities for assigned products. /li liLead other teams, as required. /li liEnsure local and global risk management plan preparation and execution throughout a medicinal product’s lifecycle. /li liFormulate clinical trial and postmarketing risk management safety strategies that are in alignment with the company's drug development and commercialization strategies. /li liPerform drug safety signal detection activities for Incyte’s 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. /li liManage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance. /li liProvide secondary medical review of ICARS 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. /li liReview 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. /li liDrive preparation of IND Annual Reports and/or DSURs for Incyte clinical trial programs, and PADERs and/or PSUR/PBRERs for marketed products. /li liPerform Health Hazard Evaluations. /li liParticipate 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 NDAs/BLAs and/or ex-US new drug submissions/variations for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs. /li liDrive 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. /li liParticipate 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. /li liContribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance, and contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific identified deficiencies of policy, procedure, or practice in GRMSS. /li liReview 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. /li liChampion 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. /li liServe as the GRMSS medical representative for joint clinical development programs with external partners as required. /li liIn the absence of the EU/UK QPPV, the GRMSS physician (or their back-up) is responsible for responding to product-related queries as delegated by the EU/UK QPPV. /li /ul h3Qualifications /h3 ul liM.D. or international equivalent. /li liMinimum of 10 years total pharmaceutical/biotechnology industry or regulatory agency experience, of which more than 5-10 years will have been in a pharmacovigilance or risk management role. /li liIn-depth knowledge of US/EU risk management/GVP landscape. /li liFirst-hand experience interacting with regulators with risk management issues. /li liExperience as an active contributor with drug registrations (Clinical Study Reports, Integrated Summaries of Safety, Summaries of Clinical Safety, and Clinical Overviews). /li liStrong interpersonal and people management skills; experience effectively leading teams. /li liStrong collaboration skills and ability to engage cross functionally. /li liPreferable (but not an absolute requirement): /li liM.P.H. or relevant epidemiology experience in industry or academia. /li liBoard certification in internal medicine or pediatrics (primary care), or hematology/oncology (specialty). /li liExperience in pharmaceutical industry activities outside the United States. /li liExperience in clinical trial development and execution. /li liTraining or experience in oncologic or inflammatory diseases, or relating to clinical safety support of oncology, immunomodulatory, or other related products. /li /ul pDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. ph3Overview /h3 pA 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. /p pHeadquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia. /p h3Job Summary /h3 pThe Senior Medical Director - 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.

Management reserves the right to change or modify such duties as required. /p pIncyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. /p pWe Respect Your Privacy /p pLearn more at: /p pThe 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. /p pDuring 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. /p pYou 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. /p pYou 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). /p pPlease contact if you have any questions or concerns or would like to exercise your rights. /p /p