Senior Director Clinical Operations - Medical Device

Job Title: Head of Clinical Operations - Medical Device

Company Overview: My client is a leading provider of innovative Medical Devices dedicated to improving patient outcomes and advancing healthcare globally. With a commitment to excellence and a passion for innovation, we are seeking a talented Head of Clinical Operations to join our dynamic team.

Position Overview: As the Head of Clinical Operations at my client, you will be responsible for providing strategic leadership and oversight for all clinical trial operations related to our Medical Devices. You will play a pivotal role in driving the development and execution of clinical strategies, ensuring the successful implementation of clinical trials in alignment with regulatory requirements and corporate objectives. This position offers a unique opportunity to lead a high-performing team and contribute to the advancement of groundbreaking medical technologies.

Key Responsibilities:

1. Strategic Planning and Execution:

   • Develop and implement strategic plans for Clinical Operations, including trial design, site selection, and patient recruitment strategies, to support the successful execution of clinical trials.
   • Lead the development and implementation of standard operating procedures (SOPs) and best practices to optimize clinical trial processes and ensure compliance with regulatory requirements.

2. Team Leadership and Management:

   • Provide leadership and guidance to the Clinical Operations team, fostering a culture of collaboration, innovation, and continuous improvement.
   • Oversee the recruitment, training, and development of Clinical Operations staff, ensuring the team has the necessary skills and resources to execute clinical trials effectively.

3. Stakeholder Management:

   • Serve as the primary point of contact for internal and external stakeholders, including clinical investigators, CROs, regulatory agencies, and key opinion leaders.
   • Collaborate closely with cross-functional teams, including regulatory affairs, medical affairs, and commercial teams, to align clinical trial activities with business objectives.

4. Quality Assurance and Compliance:

   • Ensure compliance with all applicable regulatory standards, including FDA regulations, ISO requirements, and Good Clinical Practice (GCP) guidelines.
   • Oversee quality assurance activities, including site audits and inspections, to maintain the highest standards of data integrity and patient safety.

5. Budget and Resource Management:

   • Develop and manage the Clinical Operations budget, tracking expenses and resource allocations to optimize efficiency and cost-effectiveness.
   • Evaluate and select external vendors and service providers, negotiating contracts and managing relationships to support clinical trial activities.

Qualifications:

• Advanced degree in a relevant scientific or healthcare field (e.g., MD, PhD, PharmD).
• Minimum of X years of experience in Clinical Operations leadership roles within the Medical Device industry, with a strong track record of successfully managing clinical trials from initiation to completion.
• In-depth knowledge of clinical trial design, execution, and regulatory requirements, with experience working in compliance with FDA regulations and international standards.
• Proven leadership and team-building skills, with the ability to inspire and motivate teams to achieve results in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
• Strong strategic thinking and problem-solving abilities, with a demonstrated ability to develop and implement innovative clinical trial strategies.
• Certification in clinical research (e.g., CCRA, CCRC) and/or project management (e.g., PMP) preferred.

Join Our Team: If you are a strategic thinker with a passion for driving clinical innovation and improving patient outcomes through Medical Device technologies, we invite you to apply for the position of Head of Clinical Operations at my client. Join us in our mission to revolutionize healthcare and make a meaningful difference in the lives of patients worldwide.

Application Instructions: To apply, please submit your resume/CV and a cover letter outlining your qualifications and interest in the position. We thank all applicants for their interest; however, only those selected for an interview will be contacted.

My client is an equal opportunity employer and is committed to diversity in the workplace. We encourage applications from individuals of all backgrounds and experiences.