This position has primary responsibilities for clinical research and drug safety activities with responsibility for assisting in the development and implementation of the clinical research strategy. Principalresponsibilities include, but are not limited to:
- Management and oversight of all clinical study activities.
- Recruit, manage and develop a small clinical research and drug safety/pharmacovigilance team.
- Oversee data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, and assist with manuscript preparation.
- Forecast of clinical activities and assist in developing clinical operational budget.
- May assist in oversight of clinical site management especially in regards to recruitment, monitoring, compliance and maintaining excellent partnerships with site PIs and staff to maximize subject enrollment.
- Establish and maintain excellent partnerships with contractors, vendors, CROs, and internal team members.
- Assist in development of in-house operations SOPs, guidelines and systems.
- Travel to clinical sites when needed for site recruitment and review and meetings both domestic and international.
- Participate in regulatory matters as they pertain to clinical development, in close collaboration with Regulatory Affairs.
- Provide safety surveillance for all clinical trial products for development of product safety profiles and informed consents, investigator brochures, protocols and clinical safety reports.
- Coordinate safety surveillance procedures to ensure corporate compliance with national and international adverse eventreporting requirements.
- Assures compliance with applicable regulations and standard operating procedures for the reporting of adverse events to regulatory agencies.
- Coordinate the development of guidelines and ensure the uniform and timely processing of adverse eventreports.
- Interface with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements.
- Oversee the development and preparation of reports for company management as well as external regulatory agencies.
- Oversee the preparation of NDA Safety Updates, IND (Investigational New Drug) safety reports, investigator communications, Product Labeling/Package Inserts, Risk Management Plans and other reports as necessary.
- Participate as the drug safety resource on internal teams.
- Keep company officers well informed of progress, problems and opportunities; provide weekly enrollment and program updates to senior management.
- Other matters as may be determined by the Company.
- Required: MD/DO degree.
- Ophthalmology experiencerequired; Ophthalmology residency highly preferred.
- Preferred: Active or inactive US license to practice medicine, or international equivalent.
- Prior industry experience (minimum 5 years) with knowledge of GCP, clinical trial conduct data interpretation and safety in clinical development.
- Strong organizational and communication skills are required as well as in-depth knowledge of clinical research, including FDA and international regulations, GCPs, clinical study design and documentation, conduct of clinical trials and pharmacovigilance.
- Program management skills enabling efficient planning and execution of program milestones within budget and in time.
- Ability to effectively lead, develop, mentor and manage others.
- Experience managing/overseeing large projects with both CRO and internal staff.
- Ability to interface with other functions in the company.
- Excellent verbal and written communication skills.
- Excellent interpersonal skills.
- Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve.
- Ability to work collaboratively in a dynamic and fast paced environment.