Job Title: Senior Clinical Research Director in Ophthalmology
Job ID: SANVAI0906
Contract: 8 Months
Job Location: Cambridge MA 02141
The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs and responsible for leading successful clinical trials for novel therapeutics for Ophthalmologic Diseases.
The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks.
The Sr CRD will work closely with researchers in the Client’s Genomic Medicine Unit to bring two early ophthalmology projects into development.
The Neurology, Ophthalmology and Gene Therapy Development unit is a project-based organization.
CRDs typically report to the Global Project Head and lead the cross-functional Global Clinical Team to establish the development strategy and execute the development plan.
We are looking for individuals with curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts.
• Has and maintains deep scientific, technical, and clinical expertise in ophthalmology
• 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
• Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information available
• Leads the clinical development including planned life cycle management (LCM)
• Ongoing assessment of the product benefit–risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team
• Implements strategies to identify, monitor and resolve clinical program/trial issues.
• Serves as the Study Director and Medical Monitor for a study or clinical program as well as reviewing and monitoring study data.
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other 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), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD).
• Provides clinical input to Statistical Analysis Plans, Target Product Profile and Risk Management Plan
• Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators
• Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project
• Lead the medical/clinical assessment of license-in opportunities, as needed
• Manage other CRDs and clinical scientists in the same program, as needed.
• Medical Doctor (MD) Required, Ophthalmology Specialist
• More than 5 years of clinical or scientific experience, or more than 10 years industry experience within the field of ophthalmology and retinal diseases.
• Board certified or eligible in Ophthalmology
• Completion of a fellowship program in one of the following subspecialties: medical retina/uveitis, vitreoretinal surgery, neuro-ophthalmology
• Strong scientific and academic background with deep understanding of retina and eye disease
• Clinical research or pharmaceutical experience in ophthalmology
• Knowledge of drug development
• Good networking ability in cross-cultural environment
• Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
• Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
• Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills