Expected Travel: Up to 10%
Requisition ID: 12145
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 SummaryTeleflex 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.
The position of Director, Clinical Evidence Generation requires an experienced individual with demonstrated skill and experience scoping, developing and executing clinical trial and clinical outcomes projects of diverse design. As Director, the successful candidate will also bring a track record of building and managing 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 is vital; the successful candidate will work closely and constructively with business unit executive leadership to drive execution, with Medical Directors to ensure strategic alignment.
The Director of Clinical Evidence Generation (CEG) is responsible for all clinical evidence generation activities for the US, EU, and other markets for Interventional devices.
• Oversees implementation and management of clinical studies globally 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
• 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 with our customers.
• Continuous Improvement - Demonstrates initiative and critical thinking to identify, prioritize both process and performance gaps. Develops solutions and leads the team to deliver improving results. Serves as a leader to exemplify continuous improvement thought processes and focus.
• Culture and Values – Exemplifies Teleflex values and ensures a fair, open and productive climate that is engaging, ethical and legally compliant. Leads team to work effectively across boundaries in a complex matrix environment.
• Ensure that study documents are done in collaboration with CRO (Contract Research Organizations), Data Management Group and Biostatistician
• Manage CROs as necessary
• Manages a team of clinical research resources
• Participate as a clinical representative on cross-functional project team for development of studies
• Leads, coordinates, authors, and reviews clinical filing documents
• Provide tactical management, administration and leadership in order to ensure that the project goals of time, cost and quality are met
• Performs other related duties as assigned.
• Bachelor’s degree in scientific, medical sciences, nursing, or biomedical engineering
• At least ten years of related work experience in clinical trials or outcomes research obtained in an industry-based organization.
• Prior working experience with FDA, Notified Bodies, TGA, other OUS clinical bodies
• Experience with both pre-approval and post-approval studies
• Demonstrated understanding and knowledge of Good Clinical Practice (GCP)
• HCP Engagement experience is a plus.
• Proficient in Microsoft Word, Excel, and PowerPoint required; Prezzi, Video editing, Articulate, SalesForce, VEEVA Vault or equivalent experience preferred.
• Must possess excellent verbal and written communication skills.
• Detail-oriented with strong organizational skills.
• Strong work ethic and ability to operate independently.
• Strong people skills and a team player.
• Ability to multitask, maintain timelines, and meet deadlines.
• Ability to work in a fast-paced, changing environment.
• Ability to collaborate with a broad range of personalities.
• Ability to quickly resolve challenges.
• Proven ability to successfully interact with CROs, CRAs (Clinical Research Associates), IRBs (Institutional Review Boards), EC (Ethical Committee), and other clinical authorities.
• Ability to work under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines.
• Strong leadership skills and experience, a fully engaged, hands-on professional capable of working collaboratively and independently in a small-company environment.
TRAVEL REQUIRED: up to 10%
The pay range for this position at commencement of employment is expected to be between $185,000- $195,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
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