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Associate Director, Clinical Sciences, Ophthalmology – Early Development
Johnson & Johnson. Contribute to clinical trial strategies and study-related materials, including case report forms and operational plans .
Posted 10/22/2026full-timeRaritan • New Jersey • United StatesSenior💰 $137,000 - $235,750 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including protocol development, data analysis, and regulatory compliance. Proven ability to lead cross-functional teams and mentor junior staff while ensuring high-quality clinical data integrity and innovative research methodologies.
Highest-signal resume keywords
Clinical Trial ManagementRegulatory ComplianceMedical Data MonitoringClinical Data VisualizationProtocol Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial DesignData AnalysisFirst-In-Human StudiesSafety Data ReviewBiomarker IntegrationClinical Study ReportingProject ManagementQuality AssuranceStatistical AnalysisClinical Research Methodologies
Soft Skills
Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsProblem-Solving SkillsTime Management Skills
Tools & Technologies
Microsoft Office SuiteExcelWordPowerPoint
Industry Keywords
Clinical ResearchPharmaceutical IndustryBiotechCROICH/GCPDrug DevelopmentClinical Development ProcessesStudy ExecutionGovernance MeetingsCross-Functional Teams
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Contribute to clinical trial strategies and study-related materials, including case report forms and operational plans
- Provide clinical representation for study-related review committees
- Contribute to clinical strategy execution while ensuring scientific, organizational, and regulatory compliance
- Oversee end-to-end clinical trial protocol delivery, including design, initiation, medical data monitoring, dissemination, and closeout
- Coordinate internal and external partners for timely scientific and clinical execution
- Maintain clinical data quality and integrity
- Collaborate with investigators and study teams and lead training on protocols and disease evaluation criteria
- Review, interpret, and report clinical trial data for health authority submissions
- Prepare clinical study reports, patient narratives, investigator brochures, and periodic safety updates
- Perform medical data monitoring and reporting and evaluate ongoing clinical trial data
- Liaise with clinical investigators, key opinion leaders, and external advisors
- Maintain relationships with senior management, cross-functional teams, CROs, AROs, and other vendors
- Mentor and train junior team members
- Identify process improvements and implement clinical trial best practices
- Drive innovative research methods and operational strategies
- Align clinical strategies with product development goals
- Participate in governance meetings and cross-functional initiatives
- Present clinical research findings at internal and external meetings, including regulatory interactions
- Potentially author scientific publications
- Review medical literature and new technologies
- Integrate biomarkers and digital health innovations into clinical trial designs
Requirements
What you’ll need- Minimum bachelor’s degree in a scientific or related discipline required
- Minimum 6 years of relevant experience in clinical research and development within pharmaceutical industry, biotech, CRO or equivalent
- Early development experience in drug development required, including direct experience with first-in-human (FIH) clinical studies
- Experience performing medical data review and supporting medical monitoring, including participant-level and aggregate safety data review and escalation of emerging safety concerns
- Experience developing and using clinical data visualizations for safety, tolerability, PK/PD, and biomarker trends
- Experience integrating safety, tolerability, and PK/PD data for FIH dose selection, dose-escalation reviews, and cohort-progression decisions
- Strong understanding of clinical development processes, trial design, protocol development, data analysis, regulatory guidelines, ICH/GCP, and study execution
- Demonstrated experience managing critical clinical trial aspects from conception to closure, including data management and quality assurance
- Proven ability to interpret scientific literature and apply findings strategically
- Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint
- Excellent written and verbal communication skills in English
- Strong interpersonal, organizational, analytical, problem-solving, project-management, and time-management skills
- Ability to work within cross-functional and global matrix teams
- Ability to identify issues requiring escalation and overcome project delays and obstacles
- Experience leading scientific teams and providing mentorship
- Willingness to travel domestically and internationally, approximately 10%
- Commitment to high ethical standards and workplace inclusivity
Benefits
Comp & perks- Retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; Colorado employees – 48 hours; Washington employees – 56 hours
- 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 for applicants with disabilities