Job Title: Director, Clinical Affairs
Department: Regulatory Affairs / Quality Assurance
Reports To: VP, Regulatory Affairs / Quality Assurance
Position Scope: Full-Time
Position Level: Director
Location: Boston, MA area
About XACT Robotics:
XACT Robotics is a rapidly growing medical robotics startup company. Our technology is designed to be compatible with a broad range of imaging modalities, capable of delivering various instruments to a desired target for a wide range of clinical applications and indications.
Working at XACT Robotics allows you to exercise your creativity. We encourage our employees to develop themselves, grow their careers and execute meaningful technologies that make an impact on the lives of patients.
If you have passion, drive, and a winning spirit, don`t miss this opportunity.
- Develops global clinical affairs strategies, in collaboration with regulatory affairs, marketing, research & development, and reimbursement.
- Develop and execute Clinical Affairs Strategy to generate data for both marketing and regulatory purposes.
- Provides training to clinical sites.
- Develops and maintains KOL / physician-clinician engagement.
- Prepares and manages clinical affairs budgets including all XACT funded clinical programs.
- Execute studies in the US, Israel, and EU in full compliance with all applicable GCP requirements, regulations and standards.
- Negotiates and 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.
- Prepares or assists with development of documents submitted to regulatory authorities.
- Develops clinical trial protocols and other study-related documentation.
- Develops case report forms (CRFs) and oversees database building and management.
- Initiate investigator and coordinator meetings.
- Participate in risk management and R&D meetings 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 input, when needed, to the customer complaint reportability team of adverse events and other clinical trial issues that are reportable to regulatory authorities.
- Determines membership criteria and identifies potential members for clinical events committees and data monitoring committees. Develops CEC/DMC charters and oversees committee meetings.
- Reviews and approves Clinical Risk Benefit Analyses.
- Prepares for and participates in internal/external stud y-related audits.
- Clinical Affairs SOPs, DOPs, and Work Instructions.
- Demonstrates knowledge of clinical research conduct, laws, regulations, and standards.
- Manages vendors such as CRO’s, monitors, database administrators, biostatisticians, and other consultants.
Qualifications & Requirements:
- Requires a higher education in one or more of the following fields: clinical, medical, Biology, Nursing, or other scientific discipline.
- 8-12 years’ experience in global clinical trials management. Medical device experience preferred.
- Well versed in MOH, EU, and FDA regulations and standards and GCP, ICH guidelines.
- Excellent leadership, management, collaboration, and decision-making skills.
- Outstanding written, verbal and presentation communication skills.
- Highly organized and detail oriented, with solid analytical skills.
- Demonstrated ability to manage multiple, complex, and international projects.
- Proficient in Microsoft Office software.
- Ability to travel 30%.
The above statements are intended to describe the general nature and level of work being performed by the 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.
Employee is regularly required to be independently mobile and 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.