Director, Clinical Affairs

Director, Clinical Affairs 

The Director of Clinical Affairs will oversee the design, implementation, and monitoring of clinical studies of complex medical devices including Synchron’s BCI system and ensure that the clinical studies are designed to support product performance claims, validate the products’ intended use, and meet regulatory requirements. This includes study execution, operational excellence, site management, project planning, budget, resource management and contract research organization management (as applicable) to ensure that global clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines and company goals. This role represents the clinical affairs function at Advisories, interactions with Regulatory Agencies and for evaluation of business opportunities including due diligence/fundraising. The incumbent is responsible for leadership and development of staff. 

Responsibilities 

• Work with cross-functional teams to ensure clinical studies and associated training are designed to support product performance claims, validation of the product’s intended use and global regulatory requirements  

• Ensure development of accurate study budgets, contract development and execution, payments and tracking of study expenditure 

• Develop strategic initiatives to drive the successful and timely enrollment and completion of clinical research studies to meet regulatory submissions and product market entry dates 

• Participate in strategy development and execution for specified clinical area 

• Provide comprehensive management of vendors affiliated with the project (e.g. core lab, EDC vendor, etc.) 

• Define staff responsibilities, team and personal objectives and key results to ensure goal achievement 

• Accountable for achievement of both financial and performance goals for projects and overall area of responsibility 

• Through the planning and execution of meetings and presentations, effectively communicate project goals, milestones and updates to cross-functional leadership and regulatory authorities 

• Serve as liaison with KOL professionals to operationalize aligned objectives with R&D and Commercial functions 

• Ability to manage multiple projects and work in a fast-paced, changing environment 

Minimum Qualifications   

• Bachelor’s degree in engineering, science, health science, nursing or equivalent with related experience in cardiology/neurology clinical research. 

• Minimum 10 years direct clinical affairs experience of which 3 years functioning in a lead capacity with mentoring, supervisory or demonstrated leadership role. 

Desired Qualifications   

• MS degree in engineering, science, health science, nursing or equivalent with related experience in BCI clinical research. 

• Experience working with complex device systems requiring field clinical support or in-home data collection. 

• Demonstrated clinical and scientific aptitude. 

• Results oriented. Demonstrated track record in successfully leading projects to completion on time and within budget Proven ability to galvanize clinical site staff and PIs to obtain clinical trial results. 

• Experience working in a fast paced, ever-changing startup environment. 

• Identifies and resolves issues in a proactive, creative, and timely fashion. 

• Experience with Class III active implantable medical devices. 

Skills and Knowledge   

• Proven ability to prioritize, conduct, and manage time to meet project deadlines 

• Working knowledge of ISO 14155, ICH and FDA guidances/regulations pertaining to clinical research 

• Understands interaction of quality, clinical and regulatory processes  

• Excellent negotiation and written/oral communication skills 

• Has supported BIMO audits 

At Synchron, we value our culture and the way we work together to achieve our goals. You will be among a group of hard-working, fun, and caring people who support each other and are passionate about bringing life-changing technologies to people. 

Synchron provides equal employment opportunities to all employees and applicants for employment, and prohibits discrimination and harassment of any type without regard to race, ethnicity, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  

Salary range: $180k - $200k 

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Last updated on Aug 7, 2024