Director – Connected Devices Strategic Solutions

Director – Connected Devices Strategic Solutions

Requirements

• Knowledge of FDA guidelines, different regulatory bodies and their impact on the operations
• Excellent communication and interpersonal skills
• Good technical skills related to systems
• Good team leadership skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Extensive experience with Cardiovascular monitoring devices, including Blood Pressure, Vitals, ECG, Holter & Telemetry
• Device Experience on clinical trials is a requirement, but experience working with cardiovascular monitoring on decentralized trials is also a plus
• Should understand technology and having good business Acumen, Leadership, project management skills with at least 15 years of relevant experience within the field of research managing people and operations in healthcare or pharmaceutical company; or equivalent combination of education, training and experience

Responsibilities

• Responsible to evaluate new digital health solutions for connected devices market which is in line with the strategic focus of the Connected Devices team
• Responsible to develop the new service offerings for connected devices and advise on the operational workflow for new devices. Ensure implementation of end-to-end workflow for new solutions which are in sync with the needs of the study/program and internal or external stakeholders
• Responsible to work with Vendors, Finance, and other internal stakeholders to create the entire offering including standard proposal text, budget line items and rate cards
• Develop go to market strategy, including presentations, marketing activities, pricing and conference participation
• Customer facing SME in pre-sales solution capabilities presentations, technical demos, and bid defense support
• Contribute to the creation of internal SOPs, study templates, site and patient facing materials as a Subject Matter Expert (SME) on the solution
• Responsible to provide subject matter expertise on connected devices solutions strategy keeping in mind the operational aspect of existing platforms and technologies already in use in addition to maintain an awareness of industry benchmarks and new technologies in connected device domain
• Ensure consistent and outstanding quality against department deliverables. Play a lead role in all key issues related to quality management and process improvement
• Manage customer relationships, attending client meetings to understand client expectations regarding various projects and present the operational aspects of Connected Devices team
• Maintain oversight on the development of service line budgets for RFPs
• Provide answers for customer RFIs
• Manage the standard operating procedures of the department and ensure compliance with ICH GCP guidelines
• Oversee the maintenance, review and validation of Quality Control procedures
• Plan for and manage assets for team members (software, hardware, space, supplies). This is to be done in coordination with support functions. i.e. IT for hardware, admin for space and supplies etc.
• Liaise with Business Development to give timely inputs regarding the feasibility of all new proposals going out to clients
• Responsible to retire offerings that are no longer applicable to the connected devices team

Preferred Qualifications

No preferred qualifications provided.