Clinical Scientist, Ophthalmology

Scorpion Therapeutics; Morristown (NJ); On-site; USD 100,000 - 150,000; Full time

Job summary

Scorpion Therapeutics in Morristown, NJ seeks a scientific Clinical Study Support professional to operationalize medical validation plans and oversee ophthalmology studies. You will design, execute and review trials, ensuring data integrity and regulatory readiness.

The role requires a Master’s degree (PhD/MD preferred) with 3+ years in clinical research, and ophthalmology trial experience. Collaboration with global teams and independent CRD decisions are essential.

Qualifications

• Master’s degree required; PhD/PharmD/MD preferred.
• Minimum 3+ years in clinical research/drug development.
• Ophthalmology clinical trial experience required.

Responsibilities

• Provide scientific support for ophthalmology studies by implementing validation/review plans.
• Support design and execution of multiple ophthalmology clinical studies.
• Review data listings, patient profiles and study data; partner with Data Management.
• Participate in CRF design and completion instructions.
• Assist Study start-up, site opening, enrollment monitoring, and CRD/Study Team.
• Prepare/review submissions and study documents (protocols, informed consent, reports).
• Support regulatory document filing and health authority responses.
• Contribute to centralized monitoring and data validation.
• Participate in medical information training with Study/Monitoring teams.
• Maintain ophthalmology scientific expertise; evaluate literature and benchmarks.
• Endorse CRD decisions independently.
• Assess cost elements and plan timelines.

Skills

Ophthalmology clinical trial

Clinical research data management

Regulatory/document preparation

Cross-functional collaboration

Leadership/presentation

Education

Master’s in Biomedical/Life/Pharma Sciences or related

PhD/PharmD/MD preferred

Job description

Main Responsibilities

• Clinical Study Support:
  • Provide scientific support for ophthalmology study(ies) by operationalizing the medical validation/review plan (reports and trackers)
  • Support design and execution of multiple ophthalmology clinical studies
  • Perform clinical review and analysis of data listings, patient profiles, and essential study data; partner with Data Management on queries
  • Participate in CRF design, review CRF design and completion instructions
  • Support CRD and Study Team with study start-up, site opening, enrollment monitoring, and support
• Documentation & Regulatory:
  • Prepare/review submission and study documents (e.g., protocols, informed consent, benefit-risk assessments, study plans/reports, trial disclosure)
  • Support key clinical document preparation for clinical trials
  • Support CRD with medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts
  • Support regulatory document filing and archiving
• Data Management & Quality:
  • Contribute to centralized monitoring strategy consistent with planned statistical analysis
  • Support study data validation and clinical case review (including safety events)
  • Ensure quality and updates of study documents and CRF adequacy with protocols/amendments
  • Document data collection needs quantitatively/qualitatively
• Committee & Stakeholder Management:
  • Support preparation and conduct of Study Committees (e.g., IDMC); support Steering/Data Monitoring/Adjudication committees
  • Participate in medical information training with Study Team/monitoring team
• Strategic & Scientific Contribution:
  • Maintain ophthalmology scientific/technical expertise; evaluate literature and provide clinical landscape/benchmarks; build collaborations
  • Endorse CRD decisions independently
• Project Management:
  • Assess/provide study support cost elements; plan and manage timelines

Qualifications

• Master’s required (Biomedical/Life/Pharma Sciences or related); PhD/PharmD/MD preferred
• 3+ years industry experience in clinical research and/or drug development
• Required: ophthalmology clinical trial experience

Required Skills

• Knowledge of data collection/flow/validation through analysis; data-driven, risk-managed medical review practices
• Digital/data-oriented mindset; proficient clinical literature interpretation
• Experience supporting clinical trial preparation/execution
• Basic statistical principles for analysis/interpretation/clinical relevance; translational medicine and biomarkers
• Ability to collaborate globally, communicate clearly; leadership/presentation skills; quality-focused, autonomous, proactive issue management

Preferred Qualifications

• Gene therapy/novel ophthalmology modalities; familiarity with retinal diseases (e.g., AMD, geographic atrophy)
• Experience with audit responses and regulatory inspections