Sr. Director, Global Clinical Operations (Based Remote)

Date: Aug 31, 2021

Location: Morrisville (Or Remote US), NC, US

Company: Teleflex

Expected Travel: Up to 50%

Requisition ID: 4400 

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Global Functions The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, Clinical & Medical Affairs, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. 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 Senior Director, Global Clinical Operations is responsible for leadership and execution of clinical studies in support of the direction and goals of the Company.  As an integral member of the Clinical and Medical Affairs team, this position will direct, plan, manage and coordinate the clinical operations activities in execution of clinical trials, as well as assist departmental heads within the CMA organization and across multiple business units in establishing strategic clinical study plans and objectives.  This position requires progressive leadership experience building and managing high-performing teams, a proven track record of successfully implementing substantial clinical studies, and the ability to perform at high levels in a fast-paced, dynamic environment. This position is based remotely, in the US.

Principal Responsibilities

•    Oversee content of and execution on all clinical trial related operational plans, including study operations, safety, project, monitoring, data management, data analysis, communication, and quality plans. Successfully identify, develop, and execute clinical trials inclusive of protocol development, trial enrollment, patient recruitment, data collection, monitoring, and study closure.  Engage appropriate stakeholders across departments and business units throughout study development and execution. 
•    Establish and manage department and trial budgets.  Ensure all Clinical Operations align with corporate strategy, timing and budget.  
•    Leverage and build capabilities for successful evidence generation.  Collaborate with medical affairs and other functions to support timely analysis for publications and presentations.  
•    Oversee the planning, conduct and monitoring of human clinical studies to meet regulatory requirements and guidelines.  Guide the development of clinical evaluation plans (CEP) and clinical evaluation reports (CER) that fulfill regulatory requirements such as MDR.  Facilitate risk assessments of clinical data.  Prepare or direct the preparation of required clinical study components for submission to regulatory agencies.  
•    Develop and maintain the Teleflex corporate policies and procedures related to clinical operations and authorizes their implementation.  Participate in the development and review of other corporate standards and procedures as appropriate. Participate in management reviews of the quality system as needed.
•    Identify and evaluate fundamental issues, providing strategy and direction for clinical operations.  Perform strategic analysis of trial progress and ongoing identification and implementation of improvements.  Keep abreast and inform the Company of clinical study issues or regulations of potential impact to the Company.  
•    Leverage detailed knowledge of clinical operations, business strategy, and company goals to promote new, innovative ideas.  Interact internally and externally with executive level management to negotiate critical matters related to clinical operations.  Provide clinical leadership, guidance and consultation to ensure successful product commercialization.  Collaborate across departments and business units to execute corporate objectives.  Provide clinical expertise in support of product and clinical evidence pipelines. 
•    Hire, manage, develop and motivate the Clinical Operations team to assure productivity and prevent unwanted termination.  Ensure compliance of department team and vendors with qualifications, job descriptions (if applicable) and training requirements.  Establish a culture of support, learning, efficiency, quality, and mentoring with high job satisfaction.
•    Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Teleflex complies.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving and fun!

Education / Experience Requirements

•    Minimum of bachelor’s degree in a scientific or medical field; or equivalent experience 
•    Minimum 10 years medical device experience is preferred 
•    Minimum of 5 years management overseeing clinical groups involving Class II and III devices is preferred   
•    Strong understanding of current industry best practices and ability to incorporate them into new or existing programs and processes
•    Strong knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
•    Experience developing end user programs, including training, communications and technology initiative (CTMS)
•    Strong experience leading multiple projects involving complex issues and decision-making

Specialized Skills / Other Requirements

•    Ability to identify priorities and meet deadlines in a fluid, demanding environment
•    Proficient in MS Office (Excel, Word, and PowerPoint)
•    Ability to define problems, collect data, establish facts, and draw valid conclusions  
•    Must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally
•    Flexible to changes in a dynamic environment
•    Strong negotiation and skills of persuasion
•    Ability and willingness to travel approximately 50% of the time both domestic and international. Routine travel expected to Morrisville, NC and Pleasanton, CA
•    Overnight travel will be required.

 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Raleigh