Associate Director, Field Clinical Engineering

📋 Description

• • As the Associate Director, Field Clinical Engineering, you will be a critical leader within the Implantable Device Unit, reporting directly to the Head of Device Clinical. This role is central to the strategic development and day-to-day execution of all field clinical activities, with a primary responsibility for leading and mentoring the Field Clinical Engineering (FCE) team.
• • You will be the primary point of contact for external clinical stakeholders, including neurologists, surgeons, and other medical professionals. A key aspect of your role will be to cultivate and maintain robust relationships with investigators and key opinion leaders (KOLs), fostering trust and collaboration essential for successful clinical trial execution.
• • Your leadership will extend to the recruitment, onboarding, professional development, and ongoing motivation of the FCE team. You will be instrumental in instilling a culture of accountability, high performance, and unwavering professional excellence across the team.
• • This position requires a proactive approach to coordinating complex field operations. You will serve as a crucial liaison, acting as a bridge between clinical research activities, commercial site operations, and various internal departments, ensuring seamless communication and alignment.
• • Collaboration is paramount. You will work closely with Device Development, Clinical Operations, Regulatory Affairs, Quality Assurance, and other cross-functional teams. This collaboration is vital for the successful planning, execution, and completion of clinical trials, directly contributing to Biogen's overarching business objectives and the advancement of life-changing therapies.
• • You will provide strategic oversight and direction to the FCE team, ensuring they are equipped to deliver exceptional support in the field. This includes setting performance standards, managing workloads, and fostering an environment of continuous learning and improvement.
• • A significant part of your role involves cultivating and nurturing strong, positive relationships with investigators, proceduralists, and key site personnel. These relationships are the bedrock of successful clinical trial sites and are crucial for data integrity and patient safety.
• • You will act as a primary clinical escalation resource, offering expert guidance and support during complex or challenging procedural situations encountered in the field. Your ability to provide calm, decisive leadership in high-pressure environments will be essential.
• • You will be responsible for delivering clear, effective communication, translating complex clinical considerations into actionable guidance for field teams and site staff. This ensures consistent understanding and application of trial protocols.
• • A key responsibility is to proactively identify opportunities for process improvement within field clinical operations. You will champion and support initiatives aimed at enhancing operational readiness, efficiency, and overall effectiveness.
• • You will facilitate seamless collaboration between field teams and internal departments, ensuring that valuable insights gathered from the field are effectively incorporated into study planning, protocol design, and operational strategies.
• • Your role will directly support the achievement of clinical program objectives. You will contribute to strategic decision-making processes by providing critical field-based intelligence and insights.
• • You must ensure the consistent delivery of high-quality field support across all clinical trial sites, guaranteeing strict adherence to trial protocols, regulatory requirements, and company Standard Operating Procedures (SOPs).
• • You will guide real-time responses and troubleshooting efforts to maintain the highest standards of patient safety and protocol adherence during clinical procedures.
• • Based on field experience and evolving needs, you will recommend updates to existing field procedures and documentation to ensure they remain current, effective, and compliant.
• • You will balance the immediate demands of real-time site support with a broader awareness of potential risks. This includes proactively identifying and escalating concerns to appropriate internal stakeholders to mitigate issues before they impact the trial.
• • You will serve as a mentor and provide ongoing guidance to FCE team members, fostering their professional growth and ensuring the team consistently achieves excellence in field execution.
• • This role requires a commitment to travel up to 75% of the time, often involving complex and demanding clinical environments. The ability to adapt to various locations and work effectively in a remote capacity is crucial for success.
• • You will contribute to the overall strategic direction of the Implantable Device Unit, ensuring field clinical engineering capabilities align with the company's research and development goals.
• • You will be involved in the evaluation and implementation of new technologies and methodologies within the field clinical engineering function.
• • Your expertise will be invaluable in ensuring that Biogen's clinical trials are conducted with the utmost scientific rigor and ethical integrity, ultimately contributing to the development of innovative therapies for patients.