Head of Clinical Operations

As the Head of Clinical at Senseye, you will be responsible for executing Senseye’s clinical strategy, enabling the development of our innovative mental health solution. Brining your expertise into collaboration with a stellar cross-functional team to empower Senseye on our mission to revolutionize mental health care.

Responsibilities:

• Develop a deep understanding of the data needed from the perspective of all stakeholders to develop strategy and achieve synergies.
• Successfully develop and execute on clinical strategy to enable model development and successful FDA and other global regulatory submissions.
• Maintain the highest standards of clinical excellence and patient care. Create, implement, and maintain clinical best practices, SOPs, and standards for study management.
• Stringent management and monitoring of clinical sites and the CRO.
• Collaborate with the CRO to construct and update an actionable risk mitigation plan.
• Develop clinical timelines and budget forecasts, tracking and delivering accordingly.
• Ensure regulatory compliance and the timely preparation, review, and submission of clinical documentation.
• Meticulously monitor and clean data prior to database lock, maintaining data integrity.
• Establish an operational model for oversight, tracking, and escalation of issues within studies.
• Continually evaluate the clinical program, implement optimizations, and adjust the roadmap as needed.
• Manage and grow the clinical team
• Experience with international trials or DCT a plus.
• Experience in site selection and startup as well as study closeout

Requirements

• Advanced degree in healthcare management, public health, or a related field.
• 5+ years of experience in a clinical research with some experience in a managerial role. Experience in the medical device industry strongly preferred.
• Track record of successfully implementing strategic initiatives, driving organizational growth, and improving patient outcomes.
• Proficiency in medical laws and regulations and staying updated with the latest medical advancements.
• Excellent interpersonal and communication skills, with the ability to influence and inspire diverse teams and stakeholders.
• Strong business acumen and understanding of healthcare economics, including budgeting, financial management, and resource allocation.
• Expertise in healthcare technology, digital transformation, and data analytics to drive innovation and improve clinical processes.
• Experience with international or decentralized studies a plus
• Mastered Knowledge of Good Clinical Practice (GCPs) and other healthcare regulations, accreditation standards, and legal requirements .
• Thorough understanding of EU MDR 2017/645 clinical data requirements.
• Ability to navigate complex business relationships and multiple stakeholders.

Benefits

• The freedom and trust to define your role as we design, build, and ship our products
• Competitive salary and stock option plan
• Flexible paid time off (vacation, sick leave, and public holidays)
• Flexible schedules
• Company health care plan
• Medical, dental, and vision insurance
• Short and long term disability insurance
• Life insurance policy
• 401k
• Commuter benefits for parking, public transit, carshares, etc.
• Mothers' room
• Fully stocked kitchen
• Opportunities for continuing education

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Did you know that often women apply for open jobs only if they think they meet 100 percent of the criteria listed? Men will apply to that same posting if they feel they meet 60 percent of the requirements.

We know that not everyone comes from the same background, has had the same experiences, or education, and we wouldn’t want it any other way. Don’t worry about checking every single box, instead we want you to bring your own unique outlook to the team, whatever that might be!