Senior Director Clinical Development - Ophthalmology

Senior Director, Clinical Development – Ophthalmology About the Position Location: Remote Reporting to VP Clinical Development We are seeking a Senior Director of Clinical Development to lead and drive clinical strategy, execution, and oversight of development programs. This leadership role is pivotal in shaping innovative clinical plans, managing development timelines and budgets, and collaborating with cross-functional teams, including Clinical Operations, CMC, Regulatory, Medical Affairs, Quality, Finance, and Legal. A key focus of this position is the design and execution of novel early development proof-of-concept (POC) trials, requiring strategic, outside-the-box thinking. This individual will play a critical role in clinical due diligence, guiding decision-making on development opportunities, and representing Clinical Development in internal and external stakeholder engagements. Core Responsibilities Develop and implement clinical development strategies that align with broader corporate objectives. Drive the design of early and late-stage clinical trials, ensuring rapid and robust assessment of proof-of-concept and strategic progression. Serve as a disease area expert, collaborating with Key Opinion Leaders (KOLs) and external stakeholders to refine clinical approaches. Lead cross-functional teams to ensure study execution, adherence to milestones, and alignment with regulatory requirements. Provide clinical insights into Target Product Profiles (TPPs) and contribute to strategic evaluations. Author and oversee the creation of clinical trial documents, including study protocols, clinical study reports (CSRs), statistical analysis plans (SAPs), investigator brochures (IBs), and other key regulatory submissions. Train and support study investigators on protocol execution and trial procedures. Analyze clinical trial data to generate insights that inform strategic decision-making. Maintain oversight of clinical vendors, including defining scopes of work, budget negotiations, and performance management. Drive innovation by incorporating cutting-edge methodologies and technologies into trial design. Qualifications & Expertise Advanced degree required (MD, MD/PhD, or PharmD) with a strong clinical background in Ophthalmology. At least 15 years of experience in pharmaceutical clinical development, with a minimum of 10 years in leadership roles managing clinical trial execution. Proven expertise in early-phase clinical development within Ophthalmology, with a track record of successfully designing and executing studies. Strong understanding of industry trends, treatment landscapes, and regulatory pathways, including IND and NDA processes. Ability to engage with external thought leaders, partners, and stakeholders to advance program objectives. Demonstrated leadership in cross-functional collaboration, problem-solving, and team management. Excellent communication skills with a strategic and solutions-oriented mindset. Deep knowledge of GCP, SOPs, and compliance regulations governing clinical trials. Experience working in dynamic, fast-paced environments, particularly within small or emerging biopharma organizations. #J-18808-Ljbffr