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AGTC Clinical Research Scientist in Cambridge Area, Massachusetts

Mission

The Clinical Research Scientist is responsible for assisting with the advancement of all clinical gene therapy programs. This position supports the clinical and scientific aspects of all assigned clinical programs.

Reporting Relationship

This position reports directly to the VP, Clinical Research & Medical Affairs or designee

Duties and Responsibilities

Working with the Clinical Research & Medical Affairs team, support the development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials

Review clinical trial data, including the strengths and weaknesses of study design, and the applications of results to standard of care and clinical practice

Provide support to the Clinical leadership with respect to scientific, clinical and safety monitoring issues

Support the design and development of data collection systems for all ongoing trials

Support the medical leadership in their review of both medical and clinical data to support patient eligibility decisions

With supervision, contribute to the preparation of medical and scientific data for presentations and study milestones (including meetings for Executive Team, Board of Directors, Scientific Advisory Boards [SABs] and Data and Safety Monitoring Committees [DSMC])

Provide clinical support to cross-functional departments as needed, including assay development, R&D, and Regulatory functions

With supervision, provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct

Together with medical leadership, serve as a point of contact for the clinical operations personnel, clinical trial sites and CROs for clinical science questions

Assist clinical operations personnel to manage all clinical aspects of assigned clinical studies, including assessing operational feasibility and recommending study execution plans; lead study-specific meetings; and together with the Clinical leadership serve as the clinical/medical representative for site evaluation/initiation visits, Investigator and Key Opinion Leader meetings

Assist the clinical operations personnel and data management groups in working with Reading Centers or other outside vendors to ensure that appropriate data is collected

Have extensive knowledge of the pharmaceutical/biotech industry and FDA IND, and ICH, regulations. Maintain active involvement in biotechnology and clinical affairs organizations to ensure up-to-date knowledge of current and future industry trends.

Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions

Educational Qualifications

An advanced degree, such as OD, MD, PhD, or PharmD

Additional Qualifications

Clinical Research Scientist I: No prior experience to two (2) years of experience working in clinical research

Clinical Research Scientist II: minimum of two (2) to five (5) years of experience working in clinical research

Clinical Research Scientist III: minimum of five (5) to eight (8) years of experience working in clinical research

Quality focused and well-organized

Excellent written and verbal communication skills

Ability to handle multiple tasks

Experience working with biotechnology products preferred and previous experience in ophthalmology clinical trials would be advantageous

In-depth understanding of GCP and FDA IND regulations

Understanding/working knowledge of Microsoft Word and Excel

Strong interpersonal and problem-solving skills

Strong leadership, successfully managing change, communication, analytical thinking, organization, and implementation skills

Physical Requirements

Physical demands:

☒ sedentary (< 10 lbs.)

☐ light work (< 20 lbs.)

☐ medium work (< 50 lbs.)

☐ heavy work (< 100 lbs.)

☐ very heavy work (> 100 lbs.)

Physical activity:

☒ repetitive motion

☐ balancing

☐ stooping

☐ lifting

☐ climbing

☐ kneeling/crouching

☐ crawling

☐ reaching

☒ standing

☒ typing/grasping

☒ walking

☐ pushing/pulling

☒ hearing

Visual acuity: reading and analyzing data

Working conditions: indoor office, low noise levels

Supervisor Responsibilities

This position does not require previous supervisory experience

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