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 fit

Core Competencies

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Demonstrates expertise in clinical trial management, including protocol development, data analysis, and regulatory compliance. Proven ability to lead scientific teams, mentor junior members, and drive innovative research methods aligned with product development goals.

Highest-signal resume keywords

Clinical Trial ManagementMedical Data ReviewRegulatory ComplianceClinical Development ProcessesData Visualization

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial DesignProtocol DevelopmentData AnalysisGood Clinical Practice (ICH/GCP)First-In-Human (FIH) StudiesSafety Data ReviewPK/PD Data IntegrationClinical Data MonitoringClinical Study ReportingClinical Development Process Improvement

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationInterpersonal SkillsOrganizational SkillsProblem-Solving Skills

Tools & Technologies

Microsoft Office SuiteClinical Trial Management SoftwareData Visualization Tools

Industry Keywords

Pharmaceutical IndustryBiotechCROClinical ResearchOphthalmology Clinical Development

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 execution of clinical strategies while ensuring scientific, organizational and regulatory compliance
Oversee end-to-end delivery of clinical trial protocols, 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 during trials
Lead training on study 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
Establish medical data review plans and perform medical data monitoring and reporting
Liaise with clinical investigators, key opinion leaders and external advisors
Develop relationships with senior management, cross-functional teams, vendors, CROs and AROs
Mentor and train junior team members
Identify and implement clinical development process improvements and 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, external and regulatory meetings
Author scientific publications as applicable
Review medical literature and new technologies
Integrate biomarkers and digital health innovations into clinical trial designs
May manage direct reports

Requirements

What you’ll need

Minimum of a bachelor’s degree in a scientific or related discipline
Minimum of 6 years of relevant experience in clinical research and development within pharmaceutical industry, biotech, CRO or equivalent
Early development experience in drug development, 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, Good Clinical Practice (ICH/GCP) and study execution
Experience managing critical clinical trial aspects from conception to closure, including data management and quality assurance
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 and problem-solving skills
Ability to identify program-level issues requiring escalation
Ability to manage complex projects, timelines and deliverables
Experience leading scientific teams and providing mentorship
Willingness to travel domestically and internationally approximately 10%
Commitment to high ethical standards and workplace inclusivity
Advanced degree, ophthalmology clinical development experience, generative artificial intelligence familiarity and clinical trial management software familiarity are preferred, advantageous or otherwise non-required

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 employees; 56 hours for Washington employees
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