Associate Director, Clinical Sciences, Ophthalmology (Early Development)
Johnson & Johnson · Raritan, New Jersey, United States
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research – Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
Johnson & Johnson (J&J) is seeking an Associate Director, Clinical Sciences, Ophthalmology (Early Development) to be located in Raritan, NJ or Titusville, NJ.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Specialty Ophthalmology team is focused on helping the 2.2 billion people worldwide that are affected by vision impairment. Innovating tirelessly to develop transformational treatments that preserve and restore vision. Bring your passion for health to our patient-informed team to help unlock treatments through data, science and compassion.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
The Associate Director, Clinical Science provides active scientific and strategic contributions and is responsible for contributing to the execution of clinical studies within the Therapeutic Area. This position involves collaborating with cross-functional teams, in close partnership with Study Responsible Physicians/Clinical Leads, to design, plan, and manage complex clinical trials, ensuring compliance with departmental, company, and regulatory standards. This role assists in contributing to the clinical development plan, is involved in the development of clinical trial protocols and materials and supports the completion of clinical study reports and regulatory filings. As a core member of the clinical team, the Associate Director manages matrix interactions among cross-functional members, assists with contributing to the evaluation of scientific opportunities, medical data monitoring, and drives process improvements to enhance trial efficiency and operational excellence. This role may manage direct reports, mentor colleagues, and foster a culture of continuous learning and development within the team.
Essential Job Duties and Responsibilities:
- Contribute to the development and execution of clinical trial strategies and other study-related materials (e.g. case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., protocol review committee).
- Contribute to the execution of clinical strategies for clinical trial protocols, ensuring compliance with scientific, organizational and regulatory standards.
- Oversee end-to-end delivery of a clinical trial protocol, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
- Contribute to the management and coordination of activities with internal functional partners and external partners to ensure timely scientific and clinical execution of a clinical trial.
- Contribute to the maintenance of the quality and integrity of clinical data, which is critical to the evaluation of study endpoints.
- Support interaction and collaboration with investigators and study teams during the conduct of the trial(s). Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
- Contribute to the review, interpretation, and reporting of clinical trial data, supporting accuracy and integrity for health authority submissions.
- Contribute to the preparation of documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
- Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial data (i.e. adverse events, labs, medications, etc). Establish and define medical data review plan in partnership with Study Responsible Physician. Performs medical data monitoring/reporting and evaluates ongoing clinical trial data.
- In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors.
- Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO).
- Contribute to mentorship and training of junior team members, fostering a collaborative work environment.
- Actively engage in opportunities to enhance clinical development and therapeutic area expertise.
- Identify opportunities for process improvements and implement best practices in clinical trial execution.
- Drive innovative research methods and operational strategies to enhance clinical development efficiency.
- Collaborate with cross-functional partners to align clinical strategies with overall product development goals.
- May participate in governance meetings, as appropriate, and cross-functional initiatives to promote business strategies and process improvements.
- Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions.
- May act as an author on scientific publications, as applicable, to contribute to clinical development practices and advancements.
- Research and review medical literature and new technologies to support operational planning and scientific strategy implementation.
- Integrate scientific and technological innovations into clinical trial designs, including biomarkers and digital health initiatives.
Education and Experience:
- A minimum of a bachelor’s degree in a scientific or related discipline is required. An advanced degree (e.g., MS, PharmD, PhD) is preferred.
- Requires a minimum of 6 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent.
- Early development experience in drug development is required, including direct experience with first-in-human (FIH) clinical studies
- Demonstrated experience performing medical data review and supporting medical monitoring in partnership 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, pharmacokinetic/pharmacodynamic (PK/PD), and biomarker trends and support timely study decisions.
- Experience integrating safety, tolerability, and PK/PD data to support FIH dose selection, dose-escalation reviews, and cohort-progression decisions in collaboration with Clinical Pharmacology, the Study Responsible Physician, and other functional partners.
- Strong understanding of clinical development processes, including trial design, protocol development, data