The Clinical Safety Director is responsible for developing and managing all elements of the global safety operations organization within Medtronic Clinical Operations. Specifically, this person will provide leadership in safety strategy to ensure quality and integrity of clinical data, patient safety and compliant regulatory reporting. This person will be responsible for the execution of the global safety strategy to meet Medtronic’s business goals and objectives. In addition, the Clinical Safety Director will have responsibility for clinical safety personnel across multiple regions and will work closely with the broader clinical, IT and quality organizations, including VP/Director level clinical, regulatory, quality and Clinical IT leaders, within Medtronic.
The position is also responsible to liaise with MC2 Senior Leaders and Account Management to ensure Clinical Safety services are adequately deployed and meet the needs of SBU study teams across all regions supported by MC2. This includes the expansion of safety services into new countries and geographies and increasing adoption within supported SBUs/geographies. Drives initiatives to ensure alignment and drive efficiencies within the global Clinical Safety organization to ensure strategic, process and talent development alignment. ________________________________________________________________ POSITION RESPONSIBILITIES:
- Develops and executes a global clinical safety operations strategy for the assigned area and manages global systems and initiatives in order to meet Medtronic’s business goals and objectives and drive efficiency and quality gains.
- Ensures the clinical safety operations team meets world-wide requirements for safety review, trending and reporting across SBUs/geographies. Working knowledge of the relevant regional regulations and the requirements for safety reporting (ISO/MEDDEV/FDA/CFDA/Japan GCP/MDR). Builds relationships with regional and corporate Regulatory Affairs and Quality personnel to ensure understanding, impact assessment and adoption of new and changing regulatory requirements.
- Supports MC2 Account Management in assuring the intake and execution of Safety Operations related services and projects.
- Works with Clinical IT to assess and deploy safety automation solutions to enhance compliance and drive operational efficiency.
- Ensures appropriate resources and priorities are maintained for the various global projects assigned to their area, and for the review, processing, and reporting of 90,0000 new and updated adverse events annually.
- Develops and manages the global safety cost center budget.
- Develops and coaches global & growing team of around 110 staff across multiple regions (US/EMEA/APAC) and time zones (including remote employees) including managers and individual contributors with all aspects of their responsibilities. Actively works to set & deploy strategy and objectives, promote effective work processes, team building and positive employee inclusion and engagement across all regions.
- Provides management level representation during internal and external audits and various levels of management review.
- Act as senior management sponsor for cross-BU, cross functional Safety COE to ensure that MDT is consistently executing the clinical safety process in compliance with policies, applicable International regulations for subject safety and the MDT Mission and provide governance and change management for the harmonized clinical safety process.
- Maintains a high level of professional scientific, technical and clinical expertise through familiarity with relevant industry changes, by attending trade meetings and appropriate (technical and clinical) trainings, and by interacting with various inside/outside experts or departments/institutes.
- Ensures that staff receives relevant training and development in applicable medical, technical, and regulatory areas specific to their assigned business projects.
- Responsible for continually improving partner satisfaction and formulating SUB/regional response to feedback as provided in periodic surveys.
- Responsible to assess service needs & demand and deploy Safety services in new geographies/counties (e.g. China, Japan, India, etc).
- Bachelor’s degree
- Minimum 10 years’ clinical research experience in the medical device/biologics or pharmaceutical industry with 3+ years of direct experience in clinical trials and/or safety surveillance. A science-based Ph.D. will substitute for 4 years of direct experience.
- At least 5 years’ people management experience.
- Multiregional clinical trialexperience.
- Knowledge of safety concepts, ISO, ICH and FDA guidelines related to clinical trials or advanced knowledge of the global regulatory standards related to the management of safety data and reporting.
- Proven, effective critical thinking and influence skills and demonstrated strong business acumen.
- Proven skills in leadership, management, operations and communications
- Demonstrated ability to drive organizational change and lead/motivate diverse, global teams and individuals
- Demonstrated ability to attract, develop and retain top talent
- Proven ability to work in a matrix work environment and with cross-functional teams
- Experience in managing (remotely) both managers and individual contributors
- Sensitivity to cultural differences and ability to communicate & manage effectively across cultures
- Good problem-solving skills
- Finance and budgeting knowledge; financial acumen
- Demonstrated application of clinical trial performance metrics, operational standards and safety surveillance.
- Advanced written and oral communication skills.
- Strong project management skills.
- Ability to manage a depart-wide budget and knowledge of the annual planning process
- Proficient knowledge of medical terminology
- Ability to travel at least 30% (domestic and international)