Director, Clinical Affairs
Summary of Primary Responsibilities:
The Director of Clinical Affairs is responsible for defining the vision and clinical strategies that will support meeting INSIGHTEC’s product development and commercialization objectives. The Director of Clinical Affairs is responsible for the design and successful execution of clinical trials that demonstrate medical product safety and efficacy, and ensuring that trials are conducted in full compliance to GCP and all other applicable regulatory requirements.
The Director of Clinical Affairs typically manages a staff of Clinical Project Manager(s), and external vendors such as Core Labs, Medical Monitors, Data Management, and Biostatistics. The Director of Clinical Affairs takes the leadership role for analysis and interpretation of clinical results for regulatory submissions and publications. This position reports to the VP Global Regulated Clinical Affairs. The Director position provides the Clinical Affairs department interface to executive management and is seen as one of the top leaders in INSIGHTEC.
Establish the strategic vision for the clinical affairs department:
- Partner with VP to obtain clinical trials approvals from regulatory bodies such as the FDA, Health Canada, Competent Authorities, China, Japan, etc.
- Assess clinical staffing needs and department organizational structure to align with current and future business objectives
- Lead the process of identifying, evaluating and approving clinical research projects in collaboration with Insightec stakeholders that will leverage clinical research evidence to gain regulatory approval and drive market share
- Provide knowledge and strategic planning support to the company's business units, sales and marketing, engineering and regulatory departments related to clinical research.
- Support clinical research related regulatory and compliance activities.
- Lead the clinical research team, including daily operations, resource management, budgeting, and workload prioritization.
- Develop and mentor clinical research personnel to create a best-in-class clinical research team.
- Develop SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards.
Oversee the planning, execution, and management of all clinical research studies and activities including but not limited to:
- Study design development and clinical protocols implementation
- Study submissions to “global regulatory” agencies, e.g.: FDA, Health Canada, EU, Competent Authorities, etc.
- Compliance with applicable regulatory requirements; example FDA, Health Canada, ISO, ICH/GCP, and HIPAA, etc. requirements
- Study-site assistance with IRB process and documentation preparation
- Investigator requirements, recruitment and contracts
- Study-site budgetary needs
- Timely Data collection, processing and archiving/maintenance
- Statistical analysis and interpretation of clinical data
- Final reports
- Responsible of the development of annual regulatory and compliance reporting
- As needed, support the identification, selection, and continuing management of external clinical support organizations (e.g. CROs, biostatistics support, etc).
- Ensure organizational alignment in the design and execution of initiative effort
- Establishes clearly defined department and individual goals.
- Provide leadership to include effective feedback on culture, results and future, coaching and mentoring, performance management and career development
- Develop/maintain relationships with Key opinions leaders and other professionals on issues related to Insightec research program
- Minimum 10 years of clinical research experience required
- Minimum 5 years of supervisory or management experience in clinical research required
- Minimum 5 years in senior clinical management position in biopharmaceutical or device industry.. Biopharmaceutical experience would provide a strong advantage.
- Minimum of 5 years of experience in drug development studies under FDA
- Knowledge of applicable federal and international regulations and guidelines (FDA, ISO, ICH/GCP, HIPAA, EU MEDDEV) required
- Solid track record in successfully executing Phase I – III clinical trials.
- Background in Oncology/Neuro-Oncology or Neuro-functional is preferredWell-developed verbal and written communication skills
- Detail-oriented with strong organizational skills
- Creative problem-solving and critical thinking skills
- Flexibility and willingness to work with a variety of people
- Strong technical writing skills
- Familiarity with data acquisition platforms (EDC) and firm understanding of bio-statistical concepts
- Working knowledge of MS Office, spreadsheets and graphical presentation programs; database platforms with remote EDC; CTMS, etc.
The Director of Clinical Affairs will work closely with senior management to translate business commercial objectives into requirements for specific clinical trials and programs. This role is responsible for the successful execution of the clinical portfolio as well as the management, growth and development of the clinical staff. The position requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance, as well as in-depth product knowledge and clinical / medical knowledge of indications. The position requires the individual to have strong leadership, people skills and problem-solving, and decision-making abilities.
Responsible for managing internal and external resources including Clinical Project Leader(s)/Manager(s), and vendors, core labs, medical monitors, data management, biostatistics, and investigational sites.
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