Senior Director, Clinical Evidence Generation (REMOTE)

Expected Travel: Up to 10%

Requisition ID: 12349

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. 
 
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
 
At Teleflex, we are empowering the future of healthcare.  For more information, please visit teleflex.com.

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The position of Sr. Director, Clinical Evidence Generation is a newly created position reflecting transformative change at Teleflex Interventional, driving a major investment in clinical evidence. The position requires an experienced trialist with deep operational knowledge and proven managerial and execution skills. 
The successful candidate will bring a track record of building diverse clinical research teams with competencies that include protocol design, site selection, contracting and management, consent and IRB interactions, site audit, patient safety, electronic data capture and management, and study analysis through publication of scientific publications and regulatory study reports. Experience and comfort with cross-functional oversight are vital; the successful candidate will work closely and constructively with business unit executive leadership to drive execution, with Medical Directors to ensure strategic alignment.  
Teleflex People Managers use Leadership, Clinical Acumen and Business Acumen to lead and develop their Clinical Medical Affairs team to consistently deliver high value results and capability.  They must be well planned and organized situational leaders and decision makers who use data, compassion and accountability to develop a culture of teamwork and results.

Principal Responsibilities

•    Oversees design, implementation, and management of clinical studies with responsibility for quality, timeliness and completeness of execution. 
•    Oversees creation and maintenance of study related documents including protocols, study manuals, binders, investigator’s brochure, protocol, forms, and study reports ensuring quality, methodological rigor, timeliness and consistency of methods across the enterprise.
•    Oversees contracting and drives collaboration with / productivity from external research partners, including Contract Research Organizations), Data Management Groups, Core Imaging and Biometric Laboratories, Biostatisticians, Data Safety and Monitoring committees, Event Adjudication committees, etc.
•    Serves as a knowledgeable and experienced resource for Study Managers, driving consistency of approach to study execution, problem solving and study reporting. 
•    In partnership with Finance, drives financially sound execution of all projects and the overall functional budget.
•    Ensure the team works with the Regulatory lead and Medical Director to create sound regulatory strategies.
•    Supports interactions with competent authorities and notified bodies in clinical meetings.
•    Represents the Clinical Evidence Generation team during execution of acquired evidence generation team integration arising from Corporate Development (M&A) activities.
•    Organization Capability - Proactively manages performance and team dynamics to ensure that a fair, professional and high-performance environment, aligned with company values is maintained. Develops individual and organizational capabilities to build bench strength while delivering results now and into the future. 
•    Customer Experience – Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity.  All CMA colleagues are expected to perform with the highest levels of 
professionalism, service and ethics in order to strengthen the Teleflex brand and relationship wit