Associate Director, Clinical Sciences, Ophthalmology (Early Development)

Locations: Raritan, NJ and Titusville, NJ | Job Function: Discovery & Pre-Clinical/Clinical Development | Sub Function: Clinical Development & Research – Non-MD | Category: Scientific/Technology

About the role

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.

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.
• Perform medical data monitoring/reporting and evaluate 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.

Requirements

• Minimum of a bachelor’s degree in a scientific or related discipline; advanced degree (e.g., MS, PharmD, PhD) preferred.
• 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 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 analysis, regulatory guidelines, Good Clinical Practice (ICH/GCP), and study execution.
• Ophthalmology clinical development experience preferred.
• Demonstrated experience in managing critical aspects of clinical trials, from conception to closure, including data management and quality assurance practices.
• Proven ability to interpret scientific literature and apply findings strategically within clinical projects.
• Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint; familiarity with generative artificial intelligence and clinical trial management software advantageous.
• Excellent written and verbal communication skills in English; ability to effectively present information to stakeholders.
• Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams.
• Excellent organizational skills, ability to manage multiple tasks, prioritize effectively, and respond to changing business needs in a dynamic environment.
• Proven analytical and problem-solving capabilities, with a detail-oriented mindset.
• Ability to proactively identify program level issues/discussions that require escalation.
• Ability to handle complex projects to overcome delays and obstacles to meet deadlines.
• Experience in leading scientific teams and providing mentorship.
• Strong project and time management skills; ability to develop timelines and ensure deliverables are met within project scopes.
• Willingness to travel domestically and internationally, approximately 10%, as required by project needs.
• Commitment to maintaining high ethical standards and fostering a culture of inclusivity in the workplace.

Pay

Anticipated base pay range: $137,000.00 – $235,750.00

Benefits

• Consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (Colorado residents: 48 hours; Washington residents: 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 the 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.