Director, Immunology Clinical Operations – Global Lead

Regulatory Jobs; Horsham (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is recruiting for a Director, Clinical Operations, Immunology in Horsham, PA. This role leads the Clinical Project Scientists and Medical Writers, driving evidence-generation across immunology programs with strategic and hands-on operational oversight.

You will guide budget planning, risk management, and cross-functional collaboration with Medical Affairs, Regulatory, and Global Development to deliver compliant, high-quality study deliverables and timelines.

Qualifications

• Bachelor’s degree is required.
• 10+ years of pharmaceutical/biotech experience, including clinical trial operations (Phase IIIB–IV) and at least 5 years in people management.
• Experience overseeing Company Sponsored Studies, Investigator Initiated Studies, and/or Collaborative Studies.
• Demonstrated leadership of clinical operations teams and managing complex evidence-generation portfolios.
• Expert knowledge of global clinical trials, GCP, regulatory requirements, and related procedures.
• Experience negotiating clinical research contracts with vendors and institutions.
• 10% domestic and international travel.

Responsibilities

• Lead and develop Clinical Project Scientists and Medical Writers supporting Medical Affairs evidence-generation activities.
• Set annual goals and priorities in partnership with senior leadership; align with strategy.
• Allocate internal, external, insourced, and outsourced resources across the portfolio.
• Coach and mentor team members; provide performance feedback and career development.
• Provide portfolio-level strategic oversight for Phase IIIB–IV studies, IIS, and registries.
• Translate therapeutic strategy into compliant operational execution with matrixed teams.
• Oversee study quality, timelines, budgets, and vendor management.
• Monitor risks with defined ownership, mitigation plans, and escalation pathways.
• Collaborate with Global Development, Regulatory, Safety, and other functions to ensure readiness and deliverables.

Skills

Leadership

Strategic thinking

Budgeting

Project management

Communication

Mentoring

Risk management

Cross-functional collaboration

Negotiation

Problem solving

Education

Bachelor’s degree

Advanced degree (preferred)

Job description

Johnson & Johnson Innovative Medicine is recruiting for a Director, Clinical Operations, Immunology in Horsham, PA. This role leads the Clinical Project Scientists and Medical Writers, driving evidence-generation across immunology programs with strategic and hands-on operational oversight.

You will guide budget planning, risk management, and cross-functional collaboration with Medical Affairs, Regulatory, and Global Development to deliver compliant, high-quality study deliverables and timelines.