The Associate Director/Director, Clinical Research 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 will report directly to the VP, Clinical Research.
Essential 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 clinical support to cross-functional departments as needed (including assay development, R&D, and Regulatory).
- 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.
- Support the VP, Clinical Research in the publication planning and execution process, including coordinating and overseeing medical writing and statistics vendors.
- 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.
- Assist in the development and maintenance of clinical SOPs related to GCP activities.
- Oversee the design and execution of the Safety Management Plan and, together with the VP, Clinical Research, ensure CRO accountability to all safety management activities, including AE/SAE reviews, reconciliation and patient narratives, where applicable.
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.
- Advanced degree required (PharmD, PhD, or MD)
8+ years of relevant scientific, clinical and/or drug development experience
3+ 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
Previous management or supervisory experience required