Senior Clinical Research Director, Ophthalmology

Role Summary

The Senior Clinical Research Director (CRD) is an expert clinical lead for ophthalmology development programs and is responsible for leading clinical teams to deliver successful trials for novel therapeutics in Ophthalmologic Diseases. The role requires clinical leadership, strong organizational and strategic/operational focus, resourcefulness to create synergies within the team and with external stakeholders, high emotional intelligence, self-motivation, solid analytical skills, and the ability to manage multiple operational tasks. Location: Morristown, NJ; Cambridge, MA.

Responsibilities

• Provide ophthalmology-focused medical and scientific expertise to the cross-functional project team to conduct the clinical studies from early phases to lifecycle management (LCM) programs
• Establish clinical development strategy and lead the clinical team; collaborate with medical and clinical scientific experts, clinical development scientists, in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development strategy and prepare/assist with regulatory agency interactions
• Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other operational development activities pertaining to study start-up (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment)
• Provide appropriate medical input & clinical leadership for all activities related to study conduct such as responses to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Responsible for the clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA) and answers to questions from health authorities
• Serve as the medical expert in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other clinical team members, with the capacity to train them on the medical/scientific strategy by indication

Scientific And Technical Expertise

• Has and maintains deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases
• Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
• Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders

Skills

• Designs the global clinical development strategy and generates the Clinical Development Plan in close cooperation with Regulatory Affairs and Health Economics; adjusts the strategy according to project progression
• Leads the clinical development including planned lifecycle management (LCM)
• Ongoing assessment of the product benefit–risk profile during development and LCM, in collaboration with pharmacovigilance and clinical operations
• Implements strategies to identify, monitor and resolve clinical program/trial issues
• Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data
• Provides medical input & support for activities related to clinical studies such as medical training, feasibility, medical review of data, documents, and medical information/communications for the study team and stakeholders
• Prepares/reviews key clinical documents such as meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), and CTD overview
• Provides clinical input to SAPs, TPPs and Risk Management Plans
• Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees
• Reviews Key Results Memos, Clinical Study Reports and scientific publications
• Lead medical/clinical assessment of license-in opportunities as needed
• Manage other study physicians (CRDs) and clinical scientists in the same program as needed
• Author or co-author manuscripts and abstracts
• Establishes and maintains collaborations with key opinion leaders or advisory boards
• Serves as clinical team leader/representative at global project teams, regulatory agency meetings, Steering committees, and submission task forces

Qualifications

• Required: Medical Doctor (MD) and ophthalmology residency training required; fellowship training highly preferred
• Required: Minimum 5 years of clinical trial and/or clinical development experience
• Required: Fluent in English (verbal and written)
• Preferred: Board certified or eligible in Ophthalmology
• Preferred: Strong scientific and academic background with deep understanding of retina and eye diseases
• Preferred: Clinical trial or pharmaceutical experience in ophthalmology
• Preferred: Knowledge of drug development, ocular gene therapy, regulatory strategy
• Preferred: Good networking ability in cross-cultural environment
• Preferred: Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
• Preferred: Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
• Preferred: Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills