Board Certified Ophthalmologist – Senior Medical Director

Job Description: Provides medical oversight of assigned clinical studies in the duty as a medical monitorOften serves as primary medical contact for customers for assigned clinical studiesProvides medical input and oversight in support of the Drug Safety and Pharmacovigilance departmentResponsible for protocol design and development, upon requestProvides input into protocol amendmentsDevelops and delivers project-specific and therapeutic training to project team members and clinical site staffProvides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification effortsProvides medical input into data collection tools, monitoring plans, and review and analysis plansProvides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical dataProvides after-hours medical coverage for clinical studiesRequirements: Board-certified in Ophthalmology is requiredProvides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies.Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department.Responsible for protocol design and development, upon request. Provides input into protocol amendments.Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed.Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations.Provides medical input into data collection tools, monitoring plans, and review and analysis plans.Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data.Provides after-hours medical coverage for clinical studies.Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.May provide input to clinical development or regulatory teams within the Company, upon request.May represent the Company at scientific meetings, upon request.Benefits: Health benefits to include Medical, Dental and VisionCompany match 401kEligibility to participate in Employee Stock Purchase PlanEligibility to earn commissions/bonus based on company and individual performanceFlexible paid time off (PTO) and sick time