Role Description
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Ophthalmologic Gene Therapy Development Clinical Research Physician (CRP) for LRM participates in the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of ophthalmologic products and other products, as required. This includes participating in:
-
Implementation of global clinical trials
-
Reporting of adverse events as mandated by corporate patient safety
-
Review process for protocols, study reports, publications, and data dissemination for products
-
Contacts with regulatory and other governmental agencies
-
Outreach medical activities aimed at the external clinical customer community
-
Development and implementation of the business unit and global strategy for all relevant products
The CRP serves as a scientific and medical resource with specific expertise in ophthalmology for study teams, departments, and others as needed.
Qualifications
-
Medical Doctor, board-eligible or certified in appropriate specialty/subspecialty
-
Board-eligibility or certification in ophthalmology
-
At least 5 years clinical research or pharmaceutical medicine experience desirable
-
Demonstrated knowledge of drug development process
-
Fluent in English; both written and verbal communications
-
Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills
-
Demonstrated ability to influence others
-
Ability to engage in domestic and international travel
Requirements
-
Understand and keep updated with the pre-clinical and clinical data relevant to the product(s)
-
Contribute to business unit and global alignment of clinical strategy and clinical plans
-
Collaborate with LRM leaders in the development and maintenance of a Draft Launch Label and Value Proposition
-
Plan, collaborate on, and review the scientific content of clinical documents
-
Provide oversight and input into integrated clinical development plans (ICDs)
-
Collaborate with clinical research staff in the design, conduct and reporting of clinical trials
-
Review and approve risk profiles to ensure appropriate communication of risk to study subjects
-
Participate in investigator identification and selection for clinical trials
-
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct
-
Assist in planning process and participate in study start-up meetings
-
Monitor patient safety during the conduct of studies
-
Review IIT proposals and publications, as requested by Director-Clinical/Medical
Benefits
-
Comprehensive benefit program including eligibility for medical, dental, vision and prescription drug benefits
-
Eligibility to participate in a company-sponsored 401(k) and pension
-
Vacation benefits
-
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
-
Life insurance and death benefits
-
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
-
Company bonus eligibility based on performance