Director of Clinical Affairs - VahatiCor at T45 Labs

Santa Clara, California, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Feb, 26

Salary

267000.0

Posted On

16 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Regulatory Compliance, Budget Management, Leadership, Team Development, Clinical Operations, Vendor Management, Strategic Planning, Process Improvement, Communication, Collaboration, Quality Assurance, Clinical Research, Project Management, Problem Solving, Agile Methodologies

Industry

Medical Equipment Manufacturing

Description

Title: Director of Clinical Affairs - VahatiCor Status: Full-time, Exempt Reports to: VP of Clinical Affairs - VahatiCor Overview VahatiCor is a medical device startup developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where every team member contributes to advancing solutions that improve patient outcomes. We embrace the urgency of a startup environment while maintaining the highest standards of quality and compliance. About the Role As the Director of Clinical Affairs at VahatiCor, you will be at the forefront of driving and managing the execution of clinical trials. You'll engage in strategic planning, oversee operations, and implement clinical programs, all while ensuring adherence with regulatory standards. Your focus will be on achieving operational excellence by fine-tuning our clinical operations to align seamlessly with our organizational goals. You will champion process improvements to support our clinical initiatives, playing a pivotal role in advancing innovative clinical practices. Responsibilities Strategic Leadership & Oversight Provide strategic direction and operational leadership for clinical programs, ensuring alignment with company objectives and milestones. Develop clinical operations strategies, timelines, and budgets across multiple clinical studies. Establish and implement best practices and continuous improvement initiatives to enhance operational efficiency. Build and maintain relationships with key stakeholders, including clinical investigators, regulatory bodies, CROs, and vendors. Study Management & Execution Develop and maintain study budgets. Direct the planning, execution, and management of clinical studies to ensure completion on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. Track study performance metrics, including enrollment rates, site performance, and financial forecasts, identifying and resolving deviations proactively. Develop and review clinical trial documents, such as protocols, informed consent forms, monitoring plans, and clinical databases. Ensure the integrity of the Trial Master File (TMF) and oversee documentation audits as needed. Evaluate and select clinical vendors, including CROs, and negotiate contracts in collaboration with legal and finance teams. Provide oversight of investigational product management, including accountability and reconciliation processes. Team Development and Mentorship Manage and mentor a team of Clinical Research Associates (CRAs) and other clinical staff to ensure professional growth and performance excellence. Lead cross-functional meetings, ensuring clear communication and timely follow-up on action items. Foster a culture of accountability, collaboration, and innovation within the clinical operations team. Regulatory Compliance & Quality Assurance Ensure clinical trials comply with FDA regulations, ICH/GCP guidelines, and ethical standards. Proactively identify and resolve compliance risks, working closely with quality assurance teams. Support audits and regulatory inspections, preparing teams and documentation as required. Required Experience and Qualifications Bachelor’s or Masters degree in life sciences or related field. Minimum of 10 years clinical operations, including at least three years in a leadership role within the medical device industry (cardiovascular products preferred). Hands-on experience and proven success of running early-stage clinical trials within an industry environment. Expert knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials. Demonstrated and direct experience in vendor and CRO selection/management. Strong budget management skills and ability to meet deadlines across multiple studies. Excellent leadership, mentoring, and team-building capabilities. Exceptional communication and organization skills with the ability to influence cross-functional teams. Ability to travel up to 25%. Eligibility Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas, or permanent residency (PERM) applications. Location and Compensation This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. At this time, we are not considering applicants who would need to relocate, either within or outside of California. There is no relocation package available. VahatiCor is committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package. Salary ranges are based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired. The anticipated salary range of this position is $197,000 - $267,000 based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills. Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations. Equal Opportunity Statement VahatiCor is an Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status. Third-Party Recruiter Notice We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of VahatiCor, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email careers@t45labs.com.

Responsibilities

The Director of Clinical Affairs will drive and manage the execution of clinical trials, ensuring adherence to regulatory standards and operational excellence. This role involves strategic planning, overseeing operations, and implementing clinical programs to align with organizational goals.