The Associate Director/Director, Clinical Research and Medical Affairs is responsible for assisting with the advancement of all clinical gene therapy programs. The Associate Director/Director, Clinical Research supports the clinical, scientific and strategic aspects of all ongoing clinical programs.
The Associate Director/Director, Clinical Research and Medical Affairs will report directly to the VP, Clinical Research and Medical Affairs or designee
Duties and Responsibilities
Provide medical and strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, ophthalmology, and input from the medical community while ensuring a high level of scientific integrity.
Integrate the scientific rationale, regulatory requirements, and commercial goals to build a solid strategic framework for the current and upcoming clinical trials.
Working with the VP, Clinical Research, develop innovative study designs, and design and draft clinical synopses, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials.
Analyze and interpret clinical trial data, including the strengths and weaknesses of study design and the applications of results to standard of care and clinical practice.
Provide input and guidance on scientific, clinical and safety monitoring issues.
Working with the Director of Data Management, support the design and development of data collection systems for all ongoing trials, including identifying key data for eCRF collection and data analyses.
Review medical and clinical data to support patient eligibility decisions.
Interpret, develop and prepare 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 scientific oversight and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct.
Serve as a key 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 VP, Clinical Research & Medical Affairs serve as the clinical/medical representative for site evaluation/initiation visits, Investigator and Key Opinion Leader meetings.
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
Support the VP, Clinical Research in the publication planning and execution process, including coordinating and overseeing medical writing and statistics vendors.
Assist the Clinical Research Scientist, clinical operations personnel and data management groups in working with Reading Centers or other outside vendors to ensure that appropriate data is collected.
Provide clinical support to cross-functional departments as needed (including assay development, R&D, and Regulatory).
Assist in the development and maintenance of clinical SOPs related to GCP activities.
Assist the Safety & Pharmacovigilance team with the design and execution of the Safety Management Plan and ensure CRO accountability to all safety management activities
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.
Other duties as assigned.
This job description is subject to change at any time.
Advanced degree required (PharmD, PhD, or MD)
Eight (8) or more years of relevant scientific, clinical and/or drug development experience
Three (3) or more years of progressive responsibilities in drug development, and a proven track record for clinical and scientific leadership in drug development are ideal
Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
Ability to synthesize and interpret complex information
High level of integrity, autonomy and motivation
Quality focused and well-organized
Excellent written and verbal communication skills
Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment
Demonstrated strategic and critical thinking
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
Physical demands: (check one)
☒ sedentary (< 10 lbs.)
☐ light work (< 20 lbs.)
☐ medium work (< 50 lbs.)
☐ heavy work (< 100 lbs.)
☐ very heavy work (> 100 lbs.)
Physical activity: (check all that apply)
Visual acuity: reading, writing
Working conditions: indoor office environment
This position requires previous supervisory experience.
Measures of Performance
An initial Performance Review (PR) will be completed three months from hire date.
After initial PR, reviews will be conducted annually within 60 days of the Company’s fiscal year end.
One-on-one meetings with the direct supervisor will be conducted weekly for the review of progress on work plans and data analysis.