Associate Director, Clinical Sciences, Ophthalmology (Early Development)

Johnson & Johnson•Titusville, NJ

23h•Hybrid

About The Position

Johnson & Johnson is seeking an Associate Director, Clinical Sciences, Ophthalmology (Early Development), located in Raritan or Titusville, New Jersey. The role provides scientific and strategic contributions to clinical studies within the Therapeutic Area and partners closely with Study Responsible Physicians/Clinical Leads and cross-functional teams to design, plan, and manage complex clinical trials in compliance with departmental, company, and regulatory standards. The Associate Director contributes to clinical development plans, trial protocols and materials, clinical study reports, and regulatory filings. As a core clinical team member, the role coordinates matrix interactions, supports evaluation of scientific opportunities and medical data, and improves trial efficiency and operational execution. The position may manage direct reports and includes mentoring and training colleagues. The role requires early drug-development experience, including direct experience with first-in-human studies. It includes reviewing participant-level and aggregate safety data, visualizing clinical data, and integrating safety, tolerability, PK/PD, and biomarker information to support dose selection and study decisions. Ophthalmology clinical development experience is preferred. The position requires approximately 10% domestic and international travel, as project needs require.

Requirements

Bachelor’s degree in a scientific or related discipline.
At least 6 years of relevant clinical research and development experience in the pharmaceutical industry, biotechnology, a CRO, or equivalent.
Early drug-development experience, including direct experience with first-in-human clinical studies.
Experience conducting medical data review and supporting medical monitoring with the Study Responsible Physician, including review of participant-level and aggregate safety data and identification and escalation of emerging safety concerns.
Experience developing and using clinical data visualizations to evaluate safety, tolerability, PK/PD, and biomarker trends and support timely study decisions.
Experience integrating safety, tolerability, and PK/PD data to support first-in-human dose selection, dose-escalation reviews, and cohort-progression decisions with Clinical Pharmacology, the Study Responsible Physician, and other partners.
Strong understanding of clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, ICH/GCP, and study execution.
Experience managing critical aspects of clinical trials from conception through closure, including data management and quality assurance practices.
Ability to interpret scientific literature and apply findings strategically to clinical projects.
Strong written and verbal communication skills in English, including the ability to present information effectively to stakeholders.
Strong interpersonal skills and a collaborative approach to working in cross-functional and global matrix teams.
Excellent organizational skills and ability to manage multiple tasks, prioritize, and respond to changing business needs.
Analytical and problem-solving capabilities and attention to detail.
Ability to identify program-level issues requiring escalation and manage complex projects to overcome delays and meet deadlines.
Experience leading scientific teams and providing mentorship.
Strong project and time-management skills, including developing timelines and meeting deliverables within project scopes.
Willingness to travel domestically and internationally approximately 10% as project needs require.
Commitment to high ethical standards and fostering workplace inclusion.

Nice To Haves

Advanced degree, such as an MS, PharmD, or PhD.
Ophthalmology clinical development experience.
Proficiency with Microsoft Office, especially Excel, Word, and PowerPoint.
Familiarity with generative artificial intelligence and clinical trial management software.

Responsibilities

Contribute to the development and execution of clinical trial strategies and study materials, including case report forms and operational plans; represent clinical science on study-related review committees.
Help execute clinical strategies for trial protocols while ensuring compliance with scientific, organizational, and regulatory standards.
Oversee end-to-end delivery of clinical trial protocols, including design, initiation, medical data monitoring, data dissemination, and closeout.
Coordinate internal functional partners and external partners to support timely scientific and clinical execution of trials.
Maintain the quality and integrity of clinical data used to evaluate study endpoints.
Collaborate with investigators and study teams during trial conduct.
Lead training on study protocols, disease evaluation criteria, and other clinical development components.
Contribute to review, interpretation, and reporting of trial data for accurate health authority submissions.
Help prepare clinical trial reporting documents, including clinical study reports, patient narratives, investigator brochures, and periodic safety updates.
Work with the Study Responsible Scientist and Study Responsible Physician to assess clinical trial data, including adverse events, laboratory results, and medications.
Define medical data review plans with the Study Responsible Physician and perform medical data monitoring and reporting.
Partner with the Study Responsible Physician as a liaison to clinical investigators, key opinion leaders, and external advisors.
Build and maintain relationships with internal and external stakeholders, including senior management, cross-functional teams, CROs, and AROs.
Mentor and train junior colleagues and support a collaborative work environment.
Identify process improvements and implement best practices in clinical trial execution.
Develop innovative research methods and operational strategies to improve clinical development efficiency.
Align clinical strategies with product development goals through cross-functional collaboration.
Participate in governance meetings and cross-functional initiatives as appropriate.
Prepare and present research findings at internal and external meetings, including interactions with regulatory bodies.
Contribute as an author to scientific publications when applicable.
Review medical literature and new technologies to support operational planning and scientific strategy.
Integrate scientific and technological innovations, including biomarkers and digital health initiatives, into clinical trial designs.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year, with specified state-based amounts for Colorado and 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 a child’s birth, adoption, or foster-care placement.
Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a rolling 52-week period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.