[Remote] Director, Clinical Scientist
Note: The job is a remote job and is open to candidates in USA. reputed company is an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The Director, Clinical Scientist will contribute to the implementation of Clinical Development Plans and collaborate with cross-functional teams to ensure compliance with clinical trial standards and regulatory submissions.
Responsibilities
- Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products reputed company the portfolio
- Collaborate reputed company Clinical Development and partnered Clinical Research Organizations (CROs) reputed company clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of reputed company documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs
- Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans
- Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials
- Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required
- Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in reputed company with the publication strategy for the clinical program
- Assist with reputed company site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of reputed company required clinical trial documents prior to site initiation
- Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations
- Assist with study milestones and study metrics in collaboration with clinical operations
- Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines
Skills
- A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required
- Experience in ophthalmology and familiarity with drug/device combination products
- Experience with reputed company phases of clinical drug development including regulatory submissions
- Ability to survey and interpret scientific literature reputed company to the assigned portfolio of products
- Strong communication, organizational and interpersonal skills are required
- Successful work experience in a matrix team environment with cross functional teams is required
- Independent decision-making and analytical skills are required
- Advanced degree in life science/clinical/medical field, PhD or PharmD
- Minimum of 10 years of clinical development/research and R&D experience preferred
Company Overview
Company H1B Sponsorship