Senior Clinical Scientist

Job Description

Ophthalmology Clinical Scientist:

This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross functional team.

Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:

• Serving as the lead clinical scientist on the clinical trial team.
• Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.

• Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments);
  Partners with the Study Manager on study deliverables.
• Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
• Providing tactical/scientific mentorship to other clinical scientists.

Demonstrated ability to drive and manage scientific activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

• Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
• Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
• Interact with key stakeholders across department, division, and company.
• Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
• Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Build team capabilities through proactive coaching
• Strong communication, technical writing, and presentation skills

Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience

OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/Pharm

D Degree

Degree in life sciences, preferred.

• Experience in conducting global clinical trials, including trial initiation through database lock.
• Highly Preferred: experience in conducting clinical trials in ophthalmology, such as uveitis, AMD (age-related macular degeneration), thyroid eye disease.
• Experience in developing protocols and study related documents for ophthalmology clinical trials.
• Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee for ophthalmology clinical trials.
• Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in ophthalmology clinical trials.
• Experience in performing medical monitoring in ophthalmology clinical trials
• Experience with ophthalmologic assessments, e.g (slit lamp. dilated indirect ophthalmoscopy {DIO}, imaging assessments such as optical coherence tomography {OCT}; fluorescein angiography {FA}, fundus photography {FP} and visual acuity assessments such as best corrected visual acuity {BCVA} performed in ophthalmology clinical trials.

• Adaptability
• Clinical Data
• Clinical Operations
• Clinical Study Design
• Clinical Trial Compliance
• Clinical Trial Management
• Communication
• Data Analysis
• Ethical Standards
• ICH GCP Guidelines
• Medical Writing
• Motivation Management
• Regulatory Compliance
• Regulatory Documents
• Science
• Scientific Publications
• Social Collaboration

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with…