Manager, Clinical Operations – Early Development, Oncology

Job not on LinkedIn

🔥 5 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $117k - $201.3k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

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This company has sponsored H1B visas in the past.

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• 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

• 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

• 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