Senior Director, Global Compliance at Incyte in Wilmington, DE

Job description

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. The Senior Director, Global R&D and Clinical Compliance sits on the Compliance leadership team and partners with R&D (including Clinical and Medical Affairs) and Technical Operations to support and maintain oversight of Incyte's Global Corporate Compliance Program. The Senior Director works to continuously enhance Incyte's Compliance Program and culture by understanding the legal enforcement environment and industry obligations and applying best practices in the pharmaceutical and life sciences compliance space. Essential Functions of the Job (Key responsibilities) Partner with R&D and Technical Operations to build and maintain an infrastructure that supports a company culture of compliance and recognizes that compliance is a collective responsibility of all company employees. Promote and implement enhanced Compliance Program elements within R&D and Technical Operations, including determining effective controls at the global and functional level. Conduct routine meetings with key business leaders in R&D, Clinical, Medical Affairs, and Technical Operations. Develop tools, processes and reports to support the business’s ownership of Compliance. Chair and lead the quarterly Global R&D and Clinical Compliance Committee. Establish collaborative relationships with leaders of R&D, Technical Operations, and other corporate functions and contribute to the development of Compliance annual plans and priorities based on risk assessments, leadership feedback, and other relevant inputs. Maintain a current working knowledge of laws, regulations, and industry guidance that affect the Compliance Program, with emphasis on those relevant to R&D and Technical Operations, including Good Clinical Practice (GCP) and other clinical research regulations applicable to global drug development, federal and state government price reporting laws, state and federal privacy laws such as GDPR, OIG and DOJ guidelines, the PhRMA Code, and state marketing compliance laws. Partner with Clinical Operations, Clinical Development, Biostatistics, and Medical Affairs to help ensure clinical trial design, site selection, investigator engagement, and informed consent processes comply with Good Clinical Practice (GCP), ICH guidelines, and applicable local laws and regulations. As a business advisor to global R&D and Clinical Development, provide global Compliance support to countries and functions with a clinical presence. Maintain working knowledge of healthcare professional (HCP) and healthcare organization (HCO) engagement principles, fair market value methodologies, and promotional and medical communications compliance requirements. Provide Compliance oversight and risk assessment for interactions with investigators, clinical sites, institutional review boards (IRBs)/independent ethics committees, and clinical trial vendors, including CROs and central labs. Perform similar Compliance risk oversight in collaboration with supply chain and the broader Technical Operations function, including contract manufacturers and other manufacturing and supply vendors. Support Compliance readiness for regulatory agency inspections and audits (e.g., FDA, EMA, PMDA, MHRA), including GCP inspection preparation, response coordination, and remediation tracking. Oversee Compliance processes related to clinical trial agreements, investigator and site payments, and transparency reporting obligations, including U.S. Sunshine Act/Open Payments and EFPIA disclosure requirements. Conduct Compliance re