Director, Clinical Operations, Immunology

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•Onsite

About The Position

Johnson & Johnson Innovative Medicine is recruiting a Director, Clinical Operations, Immunology, based in Horsham, Pennsylvania. The Director provides strategic and operational leadership for Clinical Project Scientists and Medical Writers within U.S. Immunology Medical Affairs, partnering with therapeutic area leadership, Medical Affairs operational counterparts, and Global Development/Post Approval Delivery Unit teams. The role translates evidence-generation strategy into compliant implementation of Company Sponsored Studies (CSS), Investigator Initiated Studies (IIS), Collaborative Studies, and other post-marketing research through insourced, outsourced, or matrixed organizations. The position provides portfolio oversight for Phase IIIB–IV, interventional, non-interventional, and registry study support, as well as clinical and scientific document delivery, portfolio planning and tracking, study and research budgets, third-party contracting, risk management, and achievement of Medical Affairs research goals. The Director develops team capabilities, addresses complex operational barriers, and drives clinical process effectiveness and continuous improvement. The role also provides operational and financial stewardship across the research portfolio and leadership for Medical Writing activities. It oversees study planning and execution, risk and quality controls, budgets and contracts, document plans and standards, and cross-functional coordination to deliver agreed scope, quality, budgets, and timelines. Grants and fellowship funding requests are outside the scope of the role. The position requires 10% domestic and international travel.

Requirements

Bachelor’s degree required.
At least 10 years of pharmaceutical, biotechnology, or related healthcare industry experience, including significant clinical trial operations or clinical project management experience supporting Phase II–IV studies.
At least 5 years of people management experience.
Experience overseeing Company Sponsored Studies, Investigator Initiated Studies, and/or Collaborative Studies.
Demonstrated leadership of clinical operations teams and complex evidence-generation portfolios, including resource planning, prioritization, coaching, people development, and performance management.
Expert knowledge of global clinical trials, drug development, Phase IIIB–IV and post-marketing research, 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 standards, and ability to oversee scientifically accurate, audience-appropriate, and compliant clinical and scientific deliverables.
Ability to develop portfolio strategy, goals, and objectives; manage complexity; and apply structured risk-management practices, including identification, assessment, prioritization, mitigation, contingency planning, monitoring, escalation, and issue resolution.
Ability to influence cross-functional partners and drive accountability in a matrix environment.
Strong financial acumen, including clinical research budget planning, forecasting, tracking, and reconciliation across a portfolio.
Demonstrated ability to review and negotiate clinical research contracts with vendors and institutions in partnership with appropriate functions.
Strong leadership, interpersonal, communication, analytical, and problem-solving skills; ability to think creatively, critically, and proactively, work independently, and manage multiple priorities with flexibility.
Willingness to travel 10% domestically and internationally.

Nice To Haves

Advanced degree in life sciences, public health, pharmacy, medicine, or business administration.
Experience leading Medical Writers or accountability for clinical and scientific document delivery.
Detailed knowledge of Immunology and the global drug development and Medical Affairs environment.
Experience leading both Clinical Project Scientists and Medical Writers or comparable multidisciplinary clinical operations teams.
Experience with publication planning, clinical study reports, manuscripts, abstracts, posters, presentations, and external scientific communications.
Process Excellence training, project management certification, or medical writing certification.
Commitment to learning emerging technologies such as AI through exploration, iteration, and applying new tools over time.
Experience building team AI literacy and confidence, reinforcing trusted and responsible AI use and sound judgment in applying AI-enabled insight.

Responsibilities

Lead, develop, and manage Clinical Project Scientists and Medical Writers supporting Medical Affairs evidence-generation activities across assigned products and therapeutic areas.
Set annual goals and objectives with senior leadership and establish priorities, accountabilities, and performance expectations aligned with Medical Affairs strategy.
Allocate internal, external, insourced, and outsourced resources across the portfolio, ensuring appropriate functional coverage, quality, and timely delivery.
Coach and mentor team members, provide 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.
Translate therapeutic strategy and enterprise plans 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 portfolio risk management, including identifying, assessing, documenting, monitoring, mitigating, escalating, and resolving operational, quality, compliance, financial, resource, vendor, and timeline risks.
Partner with Global Development/Post Approval Delivery Unit, Research and Development, Global Medical Affairs, Regulatory, Safety, Quality, Clinical Compliance, and other functions on training, audit readiness, and delivery of agreed scope, quality, budget, and timelines.
Provide operational and financial stewardship for 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 on strategic IIS and Collaborative Study guidance and proposal intake, review, approval, execution, tracking, and closeout.
Manage study and research budgets and liaise with Finance and business partners on 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 ownership, documented mitigation and contingency actions, target dates, and escalation pathways; assess aggregate and interdependent risks and escalate matters requiring leadership action.
Lead and oversee Medical Writing activities supporting the clinical study portfolio, ensuring clear, scientifically accurate, consistent, and compliant study documents and evidence-generation outputs.
Establish document plans, standards, review pathways, timelines, and quality controls; align contributors and reviewers; manage writing resources and vendors as needed; and resolve risks to 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 process effectiveness, document quality, inspection readiness, and operational efficiency.