Associate Director, Clinical Sciences, Ophthalmology (Early Development)

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

2d•$137,000 - $235,750•Hybrid

About The Position

Johnson & Johnson is seeking an Associate Director, Clinical Sciences, Ophthalmology (Early Development), based in Raritan or Titusville, New Jersey. The role provides scientific and strategic contributions to clinical studies in the Therapeutic Area and supports the development and execution of clinical trials in partnership with Study Responsible Physicians/Clinical Leads and cross-functional teams. It contributes to clinical development plans, trial protocols and materials, clinical study reports, and regulatory filings, while helping ensure compliance with departmental, company, and regulatory standards. As a core member of the clinical team, the Associate Director coordinates matrix interactions, contributes to scientific opportunity assessment and medical data monitoring, and drives improvements in trial efficiency and operational excellence. The role may manage direct reports and includes mentoring colleagues. The position requires early drug-development experience, including first-in-human studies, and collaboration on medical data review, safety monitoring, and dose-escalation and cohort-progression decisions. Approximately 10% domestic and international travel may be required.

Requirements

Bachelor’s degree in a scientific or related discipline.
At least 6 years of relevant clinical research and development experience in pharmaceutical industry, biotech, CRO, or equivalent settings.
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 study decisions.
Experience integrating safety, tolerability, and PK/PD data to support first-in-human dose selection, dose-escalation reviews, and cohort-progression decisions in collaboration 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 to closure, including data management and quality assurance.
Ability to interpret scientific literature and apply findings strategically to clinical projects.
Excellent written and verbal communication skills in English and ability to present effectively to stakeholders.
Strong interpersonal skills and a collaborative approach to cross-functional and global matrix teams.
Excellent organizational skills, ability to manage multiple tasks and priorities, and ability to respond to changing business needs.
Analytical and problem-solving skills with attention to detail.
Ability to identify program-level issues requiring escalation and handle 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 an inclusive workplace.

Nice To Haves

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

Responsibilities

Contribute to clinical trial strategies and study-related materials, including case report forms and operational plans, and provide clinical representation to study review committees.
Help execute clinical strategies for trial protocols in compliance with scientific, organizational, and regulatory standards.
Oversee end-to-end clinical trial protocol delivery, including design, initiation, medical data monitoring, data dissemination, and closeout.
Coordinate with internal functional partners and external partners to support timely scientific and clinical execution.
Help maintain clinical data quality and integrity for study endpoint evaluation.
Collaborate with investigators and study teams during trials; lead training on protocols, disease evaluation criteria, and clinical development processes.
Review, interpret, and report trial data to support accurate health authority submissions.
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 trial data, establish medical data review plans, and conduct medical data monitoring and reporting.
Partner with the Study Responsible Physician as a liaison to clinical investigators; foster relationships with key opinion leaders and external advisors.
Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional teams, CROs, and AROs.
Mentor and train junior team members and contribute to a collaborative work environment.
Build clinical development and therapeutic area expertise; identify process improvements and implement best practices in trial execution.
Drive 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 regulatory interactions.
Contribute as an author to scientific publications, as 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 applicable policy and date of hire.
Sick time: 40 hours per calendar year, with specified higher amounts for employees residing in Colorado or Washington.
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: up to 240 hours for an immediate family member and 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.