Manager, Clinical Operations – Early Development, Oncology

Johnson & Johnson

. Provide strategic and operational management for early development and clinical pharmacology trials across multiple therapeutic areas .

Posted 10/7/2026full-timeRemote • Pennsylvania • United StatesSeniorLead💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing clinical trials, ensuring compliance with ICH-GCP and regulatory requirements, and leading teams in a fast-paced environment. Proficient in resource allocation, financial management, and fostering team development while maintaining strong stakeholder communication.

Highest-signal resume keywords

Clinical Research ExperienceICH-GCP ComplianceLeadership and Team DevelopmentFinancial Management SkillsEffective Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory RequirementsDrug Development KnowledgeData Synthesis and EvaluationResource AllocationBudget ManagementIssue ResolutionPerformance EvaluationTraining and DevelopmentAI Literacy

Soft Skills

Interpersonal SkillsNegotiating SkillsOrganizational SkillsTeam ProductivityFlexible Mindset

Industry Keywords

Health Care ComplianceED&CPCROInvestigational SiteSOPsCAPAStakeholder CommunicationTherapeutic AreasContinuous ImprovementCredo-based Culture

About the role

Key responsibilities & impact

Provide strategic and operational management for early development and clinical pharmacology trials across multiple therapeutic areas
Manage resource allocation, timelines, budgets, SOPs, policies, Health Care Compliance, and local regulatory requirements
Provide line management to Trial Managers, Site Managers, Clinical Trial Assistants, and other GCO staff
Set goals and objectives, conduct performance evaluations, and support talent development
Forecast resource needs and collaborate with Flex Resource managers on hiring, onboarding, offboarding, and performance feedback
Interview, hire, develop, and train staff
Ensure direct-report training compliance and understanding of relevant processes
Support issue resolution and stakeholder communication with Ethics Committees, Health Authorities, Investigational Sites, and study teams
Support organizational change implementation and communicate priority shifts
Review and approve expenses in accordance with company policies
Provide coaching and mentorship, including accompanied site visits when appropriate
Define and execute long-term ED&CP organizational strategy
Oversee clinical trials from feasibility through close-out and ensure inspection readiness
Ensure operational objectives comply with ICH-GCP, SOPs, and procedural documents
Escalate issues and report suspected fraud, scientific/ethical misconduct, and health care compliance breaches
Contribute to CAPA and issue resolution
Build relationships with ED&CP, GCO, Country Head, Local Operating Company, and other stakeholders
Develop country ED&CP capabilities and collaborate on study placement
Oversee feasibility and site selection to deliver country commitments and strategic goals
Lead metrics reviews and follow-up actions
Ensure quality oversight and inspection readiness
Oversee local ED&CP budgets and financial reporting
Implement local processes and regulatory requirements for Late Development and Early Development teams
Contribute to new processes and systems for ED&CP study management
Foster continuous improvement, innovation, and a Credo-based culture

Requirements

What you’ll need

Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 8 years of clinical research experience in pharmaceutical industry, CRO, or investigational site
ED&CP previous clinical trial experience preferred
Demonstrated AI literacy and an AI-enabled mindset, including responsible application of AI tools in daily work
Effective communication and leadership skills
Ability to foster team productivity and cohesiveness
Experience mentoring/coaching others; line management experience desirable
Skilled in leading, hiring, training, developing, and evaluating people
Solid decision-making and financial management skills
Effective issue resolution and contingency planning abilities
Excellent knowledge of drug development, clinical research operations, regulatory requirements, ICH-GCP, HCC, and applicable regulations
Ability to synthesize and evaluate data from various reports and sources
Effective communication with internal and external stakeholders
Flexible mindset and ability to work in a fast-paced, fast-changing environment across different therapeutic areas
Ability to operate under limited supervision
Proficient in English
Computer literacy
Strong interpersonal and negotiating skills
Excellent organizational skills
Ability to collaborate and handle multiple priorities within a matrix environment
Ability to perform activities in a timely and accurate manner

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview accommodations
Equal opportunity employment