Global R&D & Clinical Compliance Leader

Incyte Corporation; Wilmington (DE); On-site; USD 180,000 - 240,000; Full time

Job summary

Incyte Corporation, a global biopharmaceutical company headquartered in Wilmington, Delaware, seeks a Senior Director, Global R&D and Clinical Compliance to lead our compliance program across R&D, Clinical and Technical Operations. You will shape policy, training, monitoring, and audits to ensure adherence to GCP, privacy laws, and regulatory requirements worldwide.

You will partner with Clinical Operations, Regulatory Affairs and Quality Assurance to align controls with submissions and

Qualifications

• Bachelor's degree required. Advanced degree preferred.
• Minimum of 10 years of pharmaceutical or life sciences company experience in healthcare compliance.
• Proven track record building a compliance culture.
• Knowledge of laws and guidance affecting the pharmaceutical industry.
• Experience supporting R&D, Medical Affairs and Technical Operations globally.
• Direct GCP, clinical trial operations or clinical research compliance experience preferred.
• Ability to lead cross-functional teams and projects.
• Strategic leadership with strong judgment and business acumen.
• Strong problem solving and risk analysis skills.
• Ability to travel as necessary.

Responsibilities

• Promote and implement enhanced Compliance Program elements within R&D and Technical Operations.
• Conduct routine meetings with key business leaders in R&D, Clinical, Medical Affairs, and Technical Operations.
• Develop tools, processes and reports to support compliance ownership.
• Chair and lead the quarterly Global R&D and Clinical Compliance Committee.
• Establish collaborative relationships and contribute to annual compliance plans based on risk inputs.
• Maintain knowledge of laws and guidance affecting the Compliance Program, including GCP and privacy laws.
• Ensure trial design and site processes comply with GCP/ICH and local regulations.
• Provide global Compliance support to countries with a clinical presence.
• Maintain knowledge of HCP/HCO engagement principles and promotional compliance requirements.
• Oversee interactions with investigators, sites, IRBs/ethics committees, and CROs.
• Support readiness for regulatory inspections (FDA, EMA, etc.) and open payments disclosures.
• Conduct compliance reviews of business activities and sponsorships.
• Provide updates to the CCO and Global Compliance Committee.
• Lead risk-based monitoring and annual monitoring plans with corrective actions.
• Advise on investigator-initiated trials, research grants, and donations.
• Align compliance with Regulatory Affairs and Quality Assurance submissions.
• Identify training needs and develop content; collaborate with Legal and Policy teams.
• Mentor and develop team members to foster a high-performing environment.

Education

Bachelor's degree

Advanced degree preferred

Job description

Incyte Corporation, a global biopharmaceutical company headquartered in Wilmington, Delaware, seeks a Senior Director, Global R&D and Clinical Compliance to lead our compliance program across R&D, Clinical and Technical Operations. You will shape policy, training, monitoring, and audits to ensure adherence to GCP, privacy laws, and regulatory requirements worldwide.

You will partner with Clinical Operations, Regulatory Affairs and Quality Assurance to align controls with submissions and