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Careers At Incyte Corporation

Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.


Medical Director, Global Risk Management and Safety Surveillance

Department: Pharmacovigilance
Location: Incyte Corporate Headquarters

 

Medical Director, Global Risk Management and Safety Surveillance

Job Summary:

The Medical Director, Global Risk Management and Safety Surveillance (GRMSS), reporting into the Head of GRMSS, will be 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 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 case safety report and aggregate levels (within the company and in collaboration with co-development 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.

Essential Functions of the Job:

  • Lead Safety   Management Team and direct all safety risk management activities for assigned   products.
  • Ensure local and   global risk management plan preparation and execution throughout a medicinal   product’s lifecycle.
  • Formulate   clinical trial and post marketing risk management safety strategies that are   in alignment with the company's drug development and commercialization   strategies.
  • Perform drug   safety signal detection activities for Incyte’s portfolio of development 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 balance.
  • Medically review   individual case safety reports (ICSRs) and provide follow-up guidance to case   operations team to ensure consistent high-quality ICSRs.
  • Review periodic   literature surveys of new and important information regarding Incyte   products, as well as relevant products from collaboration partners,   potentially impacting human safety, both in conjunction with external   collaboration partners and independently within Incyte.
  • Drive preparation   of IND Annual Reports and/or DSURs for Incyte clinical trial programs, and   PADERs and/or PSURs for marketed products.
  • Perform Health   Hazard Evaluations.
  • Participate   significantly in the development and production of integrated summaries of   safety, clinical overviews, and other registration documents for new and   supplemental NDAs and/or ex-US new drug submissions 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 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 and/or corrective action plans as they pertain to specific   identified deficiencies of policy, procedure, or practice in RMSS.
  • 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 (AE) 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 stakeholders (eg,   regulators and commercial collaborators).
  • Serve as the RMSS   medical representative for joint clinical development programs with external   partners as designated by the Head, RMSS.
  • Other responsibilities, as necessary.

Qualifications:

 

  • M.D. or   US/international equivalent. 
  • 5 years total pharmaceutical/biotechnology   industry experience,   of   which   more than 2 years   will   have   been in a pharmacovigilance or risk management role.
  • In-depth knowledge of US/EU risk management/GVP landscape. 
  • First-hand   experience interacting with regulators with risk management issues.
  • Experience as an   active contributor with drug registrations (CSRs, ISS, and Clinical   Overview).

Highly   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 hematology/oncology   (specialty). 
  • Experience in   pharmaceutical industry activities outside the United States.  
  • Experience in   clinical trial development and execution.
  • Training or experience in oncology or inflammatory diseases, or clinical safety support of oncology, immunomodulatory, or other related products.

Incyte is an Equal Opportunity Employer.

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