Senior Director, Global Compliance

Incyte Corporation•Wilmington, DE

About The Position

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 role continuously enhances the Compliance Program and culture by applying knowledge of the legal enforcement environment, industry obligations, and best practices in pharmaceutical and life sciences compliance. The position partners with global business leaders to build compliance infrastructure, implement program elements and controls, assess risks, and develop annual plans and priorities. It provides compliance advice and oversight across clinical research, R&D, Medical Affairs, Technical Operations, vendors, and global markets. The Senior Director also supports inspections and audits, monitoring and remediation, transparency and payment processes, training and policy development, and regular reporting to compliance and executive leadership. The role includes coaching and mentoring colleagues and may require travel as necessary.

Requirements

Bachelor’s degree required.
At least 10 years of pharmaceutical or life sciences company experience managing key components of healthcare compliance programs.
Demonstrated success building a compliance culture.
Knowledge of and experience with laws, regulations, and industry guidance affecting the pharmaceutical industry.
Ability to lead and work effectively with cross-functional teams and projects.
Strategic leadership capability and ability to influence without direct authority.
Strong organizational awareness, sound judgment, and business acumen; ability to make decisions with appropriate stakeholder input.
Strong problem-solving and risk-analysis skills.
Ability to prioritize effectively in a fast-paced environment and handle multiple complex and confidential tasks.
Ability to travel as necessary.

Nice To Haves

Advanced degree preferred.
Experience with compliance best practices, including working in global markets supporting R&D, Medical Affairs, and Technical Operations.
Direct experience with Good Clinical Practice (GCP), clinical trial operations, or clinical research compliance strongly preferred.

Responsibilities

Partner with R&D and Technical Operations to build and maintain infrastructure that supports a company culture of compliance and shared responsibility.
Promote and implement enhanced Compliance Program elements within R&D and Technical Operations, including determining effective global and functional controls.
Conduct routine meetings with key leaders in R&D, Clinical, Medical Affairs, and Technical Operations.
Develop tools, processes, and reports that support business ownership of Compliance.
Chair and lead the quarterly Global R&D and Clinical Compliance Committee.
Build collaborative relationships with R&D, Technical Operations, and corporate function leaders, and contribute to annual Compliance plans and priorities based on risk assessments and other inputs.
Maintain current working knowledge of laws, regulations, and industry guidance affecting the Compliance Program, especially requirements relevant to R&D and Technical Operations.
Partner with Clinical Operations, Clinical Development, Biostatistics, and Medical Affairs to support compliance of clinical trial design, site selection, investigator engagement, and informed consent processes with GCP, ICH guidelines, and applicable laws.
Provide global Compliance support to countries and functions with a clinical presence as a business advisor to global R&D and Clinical Development.
Maintain working knowledge of HCP and 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, IRBs/independent ethics committees, and clinical trial vendors; perform similar oversight with supply chain and Technical Operations vendors.
Support regulatory agency inspection and audit readiness, including GCP inspection preparation, response coordination, and remediation tracking.
Oversee Compliance processes for clinical trial agreements, investigator and site payments, and transparency reporting obligations, including U.S. Sunshine Act/Open Payments and EFPIA disclosures.
Conduct Compliance reviews of business activities such as needs assessments, external funding requests, research grants, sponsorships, charitable donations, and third-party contracts.
Provide regular updates and reports to the CCO, Global Compliance Committee, and senior and executive management on Compliance activities, audit findings, investigation outcomes, project status, risks, and proposed solutions.
Work with Compliance Monitoring & Risk Management to design and lead risk-based monitoring and auditing, using data analytics and key risk indicators to identify trends and emerging risks.
Work with Compliance Monitoring & Risk Management to develop annual monitoring plans, support their execution, and help the business complete corrective action plans promptly.
Advise on 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 Compliance Policy/Training to identify training needs, develop annual training plans and content, and deliver effective training.
Partner with Legal, Commercial Compliance Partners, and Compliance Policy/Training to identify policy needs and develop or enhance policies, SOPs, and guidance documents, ensuring business accessibility through up-to-date technology.
Contribute to a high-performing team environment through ongoing coaching and mentoring of colleagues.
Travel as necessary.