Director, Clinical Operations, Immunology

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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 IIIBIV 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 IIIBIV 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 Bachelors 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 IIIV 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 IIIBIV 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 standards with the ability to oversee scientifically accurate audience-appropriate and compliant clinical and scientific deliverables.

• Demonstrated ability to develop portfolio strategy goals and objectives; master complexity; and apply structured risk-management practices including risk identification assessment prioritization mitigation contingency planning monitoring escalation and issue resolution. Ability to influence cross-functional partners and drive accountability in a matrix environment is required.

• 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 with the ability to think creatively critically and proactively work independently and manage multiple priorities with flexibility.
• 10% domestic and international travel.

Preferred Qualifications:

• Advanced degree in life sciences public health pharmacy medicine or business administration.
• Experience leading Medical Writers or being accountable for clinical and scientific document delivery is preferred.

• 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.
• Demonstrated 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 responsible AI use and sound judgment in applying AI-enabled insight

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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