What are the responsibilities and job description for the Senior Director, Clinical Development position at ITI, Inc.?
Position Overview
The Senior Director, Clinical Development (Clinical Scientist) supports the Clinical Program Lead and Clinical Science Lead in the development of the Clinical Development Plan (CDP) and performs the relevant clinical tasks to ensure successful implementation of the CDP.
Clinical Tasks include but are not limited to the creation of the following:
- Protocols/Amendments
- Investigator Brochures
- Informed Consent Forms
- IND Annual Updates
- Clinical Sections of the DSUR
- Clinical Study Reports
- Regulatory Submissions including Meeting Requests, Briefing Books, Efficacy and Safety Summaries
- Scientific Publications
Clinical Tasks as they relate to Clinical Trials include but are not limited to:
- Representing Clinical Development as a core member on a Clinical Trial Team
- Assisting in the creation of Case Report Forms
- Providing clinical input into clinical trial documents such as lab/ECG specifications and qualification methodology associated with rater training
- Creation and review of training materials
- Coordinating the development of Medical Monitoring and Clinical Oversight Plans
- Performing clinical data review
- Assessing protocol deviations
- Assisting in the resolution of issues identified during clinical data and protocol deviation reviews
Clinical Tasks as they relate to a Clinical Program include but are not limited to:
- Providing scientific/clinical oversight for a clinical study/program and acts as a key contact regarding the scientific aspects of a project
- Developing the clinical milestones
- Developing clinical trial, regulatory and other scientific documents
- Overseeing all clinical development activities in collaboration with the relevant functional groups and Clinical Trial Teams
- Ensuring alignment amongst the relevant functional groups
- Managing the project‐related clinical development budget in conjunction with Clinical Operations and Project Management
- Providing oversight on clinical development aspects for ongoing clinical trials and act as the point of escalation within Clinical Development
- Working with Biostatistics on the analysis to be performed for a given study/submission
- Interpreting and communicating clinical trial results
- Representing Clinical Development at Regulatory Authority Meetings
- Presenting the clinical development aspects of a project and clinical trial results at internal or external meetings
- Communicating to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan
Skill Set:
- Ability to work in a team setting as well as function as an individual contributor
- Ability to work efficiently and under tight timelines
- Ability to communicate effectively
- Ability to be flexible in an ever-changing environment
- Ability to think strategically and be able to anticipate problems before they occur
- Ability to be proactive in finding solutions to issues
- Proficient in Microsoft Office (Word, Excel, PowerPoint)
Other:
- Complete all company and job-related training as assigned within the required timelines.
- Duties, responsibilities and activities may change at any time with or without notice.
Qualifications
- Relevant science degree (i.e. Master’s, PhD, MD; Bachelor’s degree considered based on experience)
- CNS experience is required
- Minimum 10 years of overall work experience or equivalent combination of experience and education
- Minimum 7 years of clinical/research experience in the pharmaceutical/device industry preferred
- Ability to travel at least 30%
- Must be able to perform all essential functions of the position, with or without reasonable accommodation
Equal Opportunity Employer
