Director, Clinical Operations, Immunology
jj · Horsham, Pennsylvania, United States
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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
People Leader
All Job Posting Locations:
Horsham, Pennsylvania, United States of America
Job Description:
Johnson & Johnson Innovative Medicine is recruiting for a Director, Clinical Operations, Immunology located in Horsham, PA.
About the Role:
The Director, Clinical Operations is a key interface to therapeutic area leadership and provides strategic and operational leadership for Clinical Project Scientists and Medical Writers within U.S. Immunology Medical Affairs. Working across assigned products and therapeutic areas, the Director partners with Medical Affairs operational counterparts and Global Development/Post Approval Delivery Unit teams to translate evidence-generation strategy into the compliant clinical and operational implementation of Company Sponsored Studies (CSS), Investigator Initiated Studies (IIS), Collaborative Studies, and other post-marketing research conducted through insourced, outsourced, or matrixed organizations. The role is accountable for Phase IIIB–IV, interventional, non-interventional, and registry study support; clinical and scientific document delivery; portfolio planning and tracking; study and research budgets; third-party contracting; risk management; and timely achievement of Medical Affairs research goals. The Director develops team capabilities, resolves complex operational barriers, and drives clinical process effectiveness and continuous improvement.
Key responsibilities include:
Lead, develop, and manage Clinical Project Scientists and Medical Writers who support Medical Affairs evidence-generation activities across assigned products and therapeutic areas.
- Set annual goals and objectives in partnership with senior leadership; establish priorities, accountabilities, and performance expectations aligned with Medical Affairs strategy.
- Allocate internal, external, insourced, and outsourced resources across the portfolio and ensure appropriate functional coverage, quality, and timely delivery.
- Coach and mentor team members, provide regular performance feedback, support career development, and build clinical operations and medical writing capabilities.
- Promote an inclusive, collaborative, accountable, and compliant culture focused on results, quality, and value to patients and stakeholders.
- Provide portfolio-level strategic oversight for Phase IIIB–IV Company Sponsored Studies, Collaborative Studies, post-marketing commitments, non-interventional research, and registries across assigned products and therapeutic areas.
- Ensure therapeutic strategy and enterprise-level plans are translated into compliant operational execution through insourced, outsourced, or matrixed teams.
- Oversee program quality, timelines, functional resource allocation, study planning, protocol and case report form development, systems testing, study trackers, Steering Committees, Data Safety Monitoring Boards, Investigator Meetings, and lessons learned.
- Establish and maintain a proactive risk-management approach across the portfolio, including early identification and assessment of operational, quality, compliance, financial, resource, vendor, and timeline risks; documentation of risk owners and mitigation or contingency plans; ongoing monitoring of risk indicators; and timely escalation and resolution of material issues.
- Partner with Global Development/Post Approval Delivery Unit, Research and Development, Global Medical Affairs, Regulatory, Safety, Quality, Clinical Compliance, and other functions to support training and audit readiness and deliver agreed scope, quality, budget, and timelines.
Provide operational and financial stewardship across the research portfolio, including Investigator Initiated Studies, Collaborative Studies, and third-party study activities.
- Partner with Therapeutic Area Leads, Medical Directors, Medical Science Liaisons, and Global Development/Post Approval Delivery Unit counterparts to develop strategic IIS and Collaborative Study guidance and support proposal intake, scientific and operational review, approval, execution, tracking, and closeout.
- Manage and maintain accountability for study and research budgets across the portfolio; serve as a key liaison with Finance and business partners for planning, forecasting, tracking, and third-party contract reconciliation.
- Oversee development, review, negotiation, and execution of clinical research contracts with vendors and institutions in partnership with Procurement, Legal, and Healthcare Compliance.
- Monitor portfolio performance, financial commitments, evidence-generation deliverables, and emerging risks through appropriate metrics and governance.
- Ensure risks and issues have clear ownership, documented mitigation and contingency actions, target dates, and escalation pathways; periodically assess aggregate and interdependent risks across studies and vendors and escalate matters requiring leadership action.
- Grants and fellowship funding requests are outside the scope of this role.
Provide leadership and oversight for Medical Writing activities supporting the clinical study portfolio.
- Ensure delivery of clear, scientifically accurate, consistent, and compliant study documents and evidence-generation outputs, which may include protocols, protocol amendments, informed consent content (when requested) and study reports.
- Establish document plans, standards, review pathways, timelines, and quality controls; align contributors and reviewers; manage writing resources and vendors (as needed); and resolve issues that could affect quality or delivery.
- Review and provide Medical Affairs input on clinical research procedures and processes, and lead cross-functional initiatives, metrics, and best practices that strengthen clinical process effectiveness, document quality, inspection readiness, and operational efficiency.
Required Qualifications:
- A minimum of a Bachelor’s degree is required.
- A minimum of ten (10) years+ of pharmaceutical, biotechnology, or related healthcare industry experience, including significant experience in clinical trial operations or clinical project management supporting Phase II–IV studies and at least 5 years of people management experience.
- Experience overseeing Company Sponsored Studies, Investigator Initiated Studies, and/or Collaborative Studies is required.
- Demonstrated leadership of clinical operations teams and complex evidence-generation portfolios, including resource planning, prioritization, coaching, organizational people development, and performance management.
- Expert knowledge of global clinical trials, drug development, and Phase IIIB–IV and post-marketing research, including Good Clinical Practice, applicable regulatory requirements, industry standards, and company procedures.
- Experience overseeing Company Sponsored Studies, Investigator Initiated Studies, Collaborative Studies, post-marketing commitments, non-interventional research, and/or registries through insourced, outsourced, and matrixed delivery models.
- Knowledge of medical writing processes and document st