Job Title: Director Clinical Affairs
Reports To: VP RA/QA
Position Scope: Full time – Manager level
The Director of Clinical Affairs is responsible for leading and managing the strategy, planning and execution of clinical research and investigational affairs for the Company, while assuring full compliance with applicable GCP regulations as well as relevant worldwide standards and regulations. Provides global leadership for Clinical Research Activities. Responsible to interface with data management, biostatistics, regulatory agents, clinical research associates, study coordinators, field clinical specialists, business stakeholders, medical/safety monitors, and functional management. Acts as the liaison with key opinion leaders, site investigators, and clinical site staff. Responsible for clinical study designs and required documentation and for all data publications including scientific publications with site investigators, white paper publications, clinical data summaries, etc.
This role requires strong technical and client management skills, the ability to work with cross functional teams: Sales, Sales Operations, Engineering, Product Management, Regulatory Affairs, and Marketing.
We are looking for a highly motivated, self-directed individual who will thrive in a fast start-up environment and possess strong interpersonal skills with multiple health system-provider types (Technologists, Physicians, Nurses, Administrators).
- Develops global clinical affairs strategies, in collaboration with regulatory affairs, marketing, research & development, reimbursement and outcomes planning, and obtain approvals by the most effective method possible.
- Develop and execute Clinical Affairs Strategy to generate data for both marketing and regulatory purposes
- Travels to clinical sites for training and clinical trials monitoring purpose
- Enroll and manage KOL / physician-clinician engagement and lead the management of all Clinical Affairs investments and required support
- Supports regulatory/clinical strategies as XACT USA clinical affairs leader.
- Prepares and manages clinical affairs budgets including all XACT funded clinical programs.
- Execute studies in the US, Israel, EU in full compliance with all applicable GCP requirements, regulations and standards
- Approves contracts and budgets with sites, CRO’s and vendors.
- Responsible for data collection, analysis, and presentation to company management
- Responsible for preparing data for publication, white papers, presentations, etc.
- Prepare and approves protocols for projects; reviews final study conduct documents such as study manuals, study plans, study tools, etc.
- Develops staffing plans according to needs.
- Initiate investigator and coordinator meetings.
- Participate in Risk management and R&D DRs representing clinical affairs
- Provides oversight of individual clinical trials to ensure full compliance with GCP and that safety concerns and/or adverse events are identified and appropriate responses to such concerns are executed.
- Provides advice to the customer complaint reportability team of adverse events and other clinical trial issues to regulatory agencies.
- Determines membership criteria and identifies potential members for clinical events committees and data monitoring committees. Reviews and approves trigger plans for CEC and DMC.
- Reviews and approves Clinical Risk Benefit Analyses.
- Reviews and approves study corrective action plans. Prepares for and participates in internal/external study-related audits.
- Develops and maintains Clinical Investigation, conduct infrastructure – drafting and/or reviewing of SOPs, DOPs, and Work Instructions.
- Demonstrates thorough knowledge of and coaches’ others in the appropriate application of clinical research conduct, laws, regulations, standards, and compliance with applicable SOPs and policies
- Other initiatives as required.
- Maintain familiarity with global medical device regulations and national certification schemes
- Participate in requested meetings and Trade Shows (demo equipment on show floor, participate in wet lab events), etc.
- Participate in professional organizations or conferences to keep abreast of developments in the relevant medical robotics.
Qualifications & Requirements:
- Requires a higher education in one or more of the following fields: clinical, medical, Biology, Nursing, Biomedical scientific/technical or legal discipline
- 8-12 years’ experience in clinical/scientific medical devices/pharmaceutical clinical trials and research
- 5 years’ experience managing projects and working with clinical professionals and cross-functional product development teams.
- Well versed in MOH, EU, and FDA regulations and standards and GCP, ICH guidelines.
- Familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies.
- Excellent leadership, management, collaboration and effective decision-making skills
- Outstanding written, verbal and presentation communication skills.
- Highly organized and detail oriented, with solid analytical skills
- Ability to understand strategic goals and match the business needs of the company.
- Ability to independently manage and provide significant tactical leadership and guidance
- Demonstrated ability to manage multiple, complex, and international projects.
PHYSICAL JOB REQUIREMENTS:
Employee is regularly required to be independently mobile, interact with a computer.
It is the policy of XACT to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, XACT will provide reasonable accommodations for qualified individuals with disabilities.
The above statements are intended to describe the general nature and level of work being performed by employee assigned to this classification. Descriptors within are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.