Vida are delighted to be in continued partnership with a revolutionary neurovascular start-up.
This innovative company is looking for a hands-on Clinical Affairs Director based in the North-East of the USA.
OVERVIEW:
The Director of Clinical Affairs is responsible for the development and execution of clinical trials and initiatives in alignment with the company strategy and objectives. The individual will collaborate closely with Regulatory, Market Development, senior leadership and other functional areas to enable successful execution of deliverables in a fast-paced and dynamic start-up environment. The individual must be able to flex between the various functions of clinical affairs and demonstrate the ability to work effectively with minimal supervision and collaboratively as part of a team.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Development and execution of global clinical trials in alignment with corporate objectives
- Ensure all requirements of International Conference on Harmonization (ICH), Good Clinical Practices (GCP), applicable HIPAA and regulatory requirements are satisfied within clinical operations
- Ability to demonstrate competence and credibility to build relationships of trust with physician investigators and associated research staff at clinical centers
- Oversee overall clinical trial site management from qualification/start-up to closeout, including support for clinical trial agreement negotiation, site training and initiation, CRF review, protocol and regulatory compliance, device accountability, and site visit reports
- Support continuous review, initiation and development of clinical centers in collaboration with field clinical operations
- Effectively train and transfer knowledge to other clinical team members
- Organize and lead clinical trial committee meetings (may include but not limited to steering committee / investigator meetings, DSMB, and site coordinator meetings)
- Manage contracts and relationship with CRO partners and other contractors/consultants
- Actively support the regulatory reporting and submission process, working closely with regulatory stakeholders in the study reporting and development and support of strategies to obtain marketing authorization for Company products
- Collaborate with Marketing/Medical Advisors on data for publications and presentations
- Support future clinical strategy development and execution as required
QUALIFICATIONS
Education/Training:
- BS or higher in a technical or clinical discipline (e.g., engineering, biology/life sciences)
- PMP or other project management credential strongly preferred
Experience:
- 10+ years clinical research or relevant experience in a medical device setting
- Experience with a Class III medical device and associated pre-market clinical trials strongly preferred
- Previous experience with vascular implants preferred
- Demonstrated experience supporting major regulatory submissions – PMA, 510(k), EU MDR, etc.
- Excellent written and analytical skills required; some formal training in statistics is preferred
- Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively in a dynamic start-up environment.
- Ability and willingness to travel as required to meet company objectives.
If interested, please click apply, send me a direct message or reach out via email:
myles@vida-cs.com
