Senior Scientist, Clinical Operations - Ophthalmology

This position drives scientific planning, strategy, and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate with global cross-functional team members including clinical directors and study managers to lead or support clinical trial scientific activities.

Responsibilities

• Responsible for the clinical and scientific execution of clinical protocol(s).
• Serves as the lead clinical scientist on the clinical trial team.
• Collaborates with the Medical Writer on clinical, scientific, and regulatory documents.
• Partners with the Study Manager on study deliverables.
• Participates in study setup and design during study start-up (e.g., database setup).
• Leads the medical monitoring team in reviewing and interpreting clinical data and medical protocol deviations in collaboration with the Clinical Director.
• Builds talent and capabilities of direct and indirect team members through proactive coaching, mentoring, and development opportunities.
• May include management of direct reports, including assignment of resources, professional development, and performance management.
• May serve as a subject matter expert and/or participate on process improvement teams.
• Represents the company through external partnerships, collaborations, and key strategic engagements.

Skills

• Demonstrated ability to drive and manage scientific activities on clinical protocols.
• Strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
• Ability to manage multiple competing priorities with strong planning, time management, and prioritization skills.
• Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
• Proactive approach, strategic thinking, and leadership driving toward study goals.
• Ability to influence opinions and decisions of internal and external customers, vendors, and stakeholders across functional areas.
• Effective delegation and assignment of activities to meet business needs.
• Problem-solving, prioritization, conflict resolution, and critical thinking skills.
• Advanced communication, technical writing, and presentation skills.

Requirements

• Bachelor’s Degree + 9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology.
• OR Master’s Degree + 6 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology.
• OR PhD/PharmD Degree + 2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience in ophthalmology.
• Degree in life sciences preferred.

Required Skills

• Clinical Data
• Clinical Protocol
• Clinical Research
• Clinical Study Design
• Clinical Trial Compliance
• Clinical Trials
• Clinical Trials Analysis
• Data Analysis
• Drug Development
• ICH GCP Guidelines
• Ophthalmology
• Regulatory Compliance
• Strategic Thinking

Pay

The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

Schedule

• 1st shift (Day).
• Travel requirements: 25%.