Senior Director, Global Compliance

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 reviews of certain business activities, e.g., needs assessments, external funding requests, research grants, sponsorships, charitable donations, and third-party contracts. Provide regular updates and reports to the CCO, the Global Compliance Committee, and senior and executive management on the operation and progress of global Compliance efforts and initiatives, audit findings, investigation outcomes, project status updates, as well as potential risks and proposed solutions. Work with internal Compliance Monitoring & Risk Management to design and lead a risk-based Compliance monitoring and auditing program, leveraging data analytics and key risk indicators to proactively identify trends and emerging risk areas across functions. Work with internal Compliance Monitoring & Risk Management to develop annual monitoring plans, support these efforts, and work with the business to complete corrective action plans in a timely manner.  Advise on the compliant structuring and oversight of investigator-initiated trials, research grants, fellowships, and scientific or charitable donations. Partner with Regulatory Affairs and Quality Assurance to align Compliance controls with regulatory submissions, inspection commitments, and quality management systems. Partner with Legal, Commercial Compliance Partners, and the internal Compliance Policy/Training function to identify training needs, develop an annual training plan, create relevant training content and conduct effective training for the business functions. Partner with Legal, Commercial Compliance Partners, and the internal Compliance Policy/Training function to identify policy and guideline needs, develop and enhance policies, SOPs, and guidance documents and ensure optimal accessibility for the business using up-to-date technology.  Contribute to a high-performing team environment that fosters growth and development through ongoing coaching and mentoring of colleagues. Qualifications (Minimal acceptable level of education, work experience, and competency) Bachelor's degree required. Advanced degree preferred. Minimum of 10 years of pharmaceutical or life sciences company experience managing key components of healthcare compliance programs. Proven track record and demonstrated success building a compliance culture. Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry. Experience in the areas of compliance best practices preferred, including working in global markets supporting R&D, Medical Affairs, and Technical Operations functions. Direct experience with Good Clinical Practice (GCP), clinical trial operations, or clinical research compliance strongly preferred. Ability to lead and work effectively with cross-functional teams and projects. Strategic leadership capability, ability to influence without direct authority, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with appropriate input from multiple stakeholders. Strong problem solving and risk analysis skills. Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks. Ability to travel as necessary. 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: http://www.incyte.com/privacy-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 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). Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.