This role provides strategic and operational leadership for Clinical Project Scientists and Medical Writers within U.S. Immunology Medical Affairs. The Director partners with operational counterparts and Global Development/Post Approval Delivery Unit teams to translate evidence-generation strategy into compliant clinical and operational implementation of various research studies. The position is accountable for study support, clinical and scientific document delivery, portfolio planning and tracking, budgets, third-party contracting, risk management, and timely achievement of Medical Affairs research goals.
Responsibilities
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
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
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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
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
Requirements
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 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
Nice to have:
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
About the Company
At Johnson & Johnson, health is everything. The company's strength in healthcare innovation empowers it to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through its expertise in Innovative Medicine and MedTech, Johnson & Johnson is uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to its employees who work throughout the world, providing an inclusive work environment where each person is considered as an individual, respecting their diversity and dignity, and recognizing their merit.
