Medical Monitor, Ophthalmology
The Medical Monitor reports to the Chief Development Officer and in this role oversees data review including the safety aspects and benefit risk evaluation of outcomes of interest in clinical trials. They collaborate with cross-functional teams, review safety data, assess adverse events, and ensure compliance with regulatory requirements. Their expertise contributes to patient safety and the successful execution of clinical studies through rigorous monitoring of data.
Reports To: Chief Development Officer
Function: Medical Safety
Level: Dependent on Candidate
Location: US
Key Responsibilities
1. Strategic Oversight:
- Collaborate with cross-functional teams to develop and implement proactive medical monitoring strategies for clinical trials related to ophthalmology.
- Medical input into safety management plans.
- Ensure alignment with study objectives, safety endpoints, and regulatory requirements.
- Provide medical input during protocol development and study design.
2. Operational Duties:
- Review and analyze safety data, adverse events (AEs), and serious adverse events (SAEs) throughout the trial.
- Assess patient safety, benefit-risk profile, and overall study conduct.
- Interact with investigators, study coordinators, and site personnel to address medical queries.
- Contribute to safety narratives, clinical study reports, and regulatory submissions.
- Plan, manage, and monitor all medical monitoring activities for assigned drugs:
- Medical safety review of Periodic Benefit Risk Evaluation Reports (PADERs), Development Safety Update Reports, etc
- Develop Risk Management Plans.
- Medical safety review of Regulatory submissions (NDA, BLA).
- Continuously monitor product safety profile.
- Set up safety analyses in post-marketing and clinical trial databases.
3. Areas of Focus:
- Ophthalmic safety assessments (e.g., visual acuity, intraocular pressure, ocular adverse events, slit lamp, cataracts, Lens Clarity Grading, Dilated Indirect Ophthalmoscopy, Hematology and Serum Chemistry, specular microscopy, etc).
- Adherence to Good Clinical Practice (GCP) guidelines.
- Risk management/ signal detection data collection and analysis strategy, evaluation and management.
Necessary Skill Set
- Ophthalmologist
- Clinical research experience, particularly in ophthalmology or related therapeutic areas.
- Strong understanding of drug development, data monitoring, pharmacovigilance, and regulatory requirements.
- Excellent communication skills to collaborate with internal and external stakeholders.
- Clinical practice experience beyond training.
- Strong medical/scientific knowledge.
- Case/medical review experience.
- Highly ethical, prioritizing patient safety.
- Self-starter with a willingness to take on responsibilities.
- Ability to synthesize large amounts of medical data and draw medical conclusions.
- Understanding of the pharmaceutical industry and regulatory environment.
Qualifications
- Medical degree (MD or equivalent) with specialization in ophthalmology required
- Minimum of 5 years’ experience with clinical trials, safety monitoring, and ophthalmology.
If you wish to apply, please use the application button below and send us your letter of intent and resume.
Oculis is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply.