Director, Clinical Operations

We are seeking an accomplished leader to join our team as Director of Clinical Operations. This role involves collaborating with members of the clinical development team to lead clinical studies. This role includes leadership responsibilities, ensuring clinical trials align with protocols, SOPs, GCP and regulatory requirements, and serving as a key liaison with CROs and other vendors. In addition, they will identify recruitment strategies and drive operations in the implementation of those strategies working very closely with all relevant stakeholder groups.

• Oversee the execution of clinical trials.
• Experience in conducting site feasibility and highlights country specific strengths and opportunities in the creation of the strategy for selection of countries/sites.
• Ensures timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans to enable effective and efficient delivery to plan.
• Collaborates with key stakeholders to define strategies which supports the study team to achieve study objectives.
• Manages vendor budgets and contracts.
• Tracks and reports study metrics.
• Identifies and mitigates operational risks related to study implementation and compliance.
• Builds and maintains relationships with investigators and key opinion leaders. Offers technical expertise in developing clinical documents and conducting trials.
• Stays current with industry practices and regulatory requirements.
• Regularly communicates with stakeholders including Regulatory, Clinical Development, Legal, and Finance colleagues.
• Leads/contributes to the CRO management and selection process as needed.
• Leads/attends key meetings to ensure study goals are met.
• Contributes to the development and implementation of clinical operations initiatives.
• Able to work independently, giving regular study updates in internal and external meetings.
• Identifies, reviews, and tracks departmental objectives, metrics and key results.
• Provides mentorship and guidance to team members as required.
• Contributes to cross-functional corporate initiatives.
• Develops strategic relationships to improve AAVantgarde’s access to sites and patients.
• Line management of team members in line with business needs and expectations. This may include but not limited to Clinical Operations roles in the following areas - study management, site engagement, and/or other local staff working from the European region.

Skills and Experience Required

The successful candidate will possess extensive experience leading clinical trial operations across various trial phases with ophthalmology Gene therapy experience preferred, but not essential. You must also have experience in leading clinical trial operations, including multi-country, multi-centre trials. You will have strong leadership and management skills and a comprehensive knowledge of the clinical development process and regulatory requirements. The successful candidate will have proven success in managing in-house and outsourced clinical operations directly or via vendors. You will be proficient in financial budgeting and reporting experience and have the ability to effectively interact and collaborate with various stakeholders at all levels of the organisation. You must have previous experience collaborating and contracting with clinical trial sites. Experience working with ophthalmology sites is desirable, though not essential. You will also be a proven leader with line and performance management experience, functional management experience, managing resourcing and budget planning and oversight.

Equal Opportunities

At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.

Recruitment Policy

AAVantgarde’s HR team leads all recruitment activities for AAVantgarde globally. AAVantgarde will not recognise any notional ownership recruitment companies claim to hold over candidates they present directly to hiring managers without the AAVantgarde HR team’s consent, nor any fees the recruitment company may feel are due as a result of this. Unsolicited resumes sent to AAVantgarde from recruiters do not constitute any type of relationship between the recruiter and AAVantgarde and do not obligate AAVantgarde to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees. If you are interested in becoming a recruitment partner please email the HR team at recruitment@aavantgarde.com