Sr. Manager, Clinical Operations (Based Remote - US)

Date: Jul 28, 2022

Location: Dallas, TX, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 6613

 

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.

 

Interventional Urology – NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract’s focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 175,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. 

 * No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

  1. Roehrborn, J Urology 2013 LIFT Study
  2. McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

Position Summary

The Sr. Manager, 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 Global Clinical Operations (GCO) team, this position establishes operational objectives, policies, procedures, and work plans to execute all aspects of multi-center global clinical trials independently, from concept to close-out within designated project budgets and timelines. 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.

** Position can be based remotely, within the US.**

Principal Responsibilities

Manage the clinical evidence generation plans for the Interventional Urology business unit.

•    Drive the development of study metrics, research objectives and risk management methodology that is applied globally in clinical operations.
•    Ensure all applicable international and/or local statutes governing human participation in clinical testing and research studies are followed.
•    Ensure clinical studies can withstand audit scrutiny by any Regulatory entity where the risk of failure can affect the business or the product/solution.
•    Identify program risks and proactively create and implement mitigation strategies.
•    Regularly interact with executives or major customers. Interactions frequently involve special skills, such as negotiating with customers and influencing senior level leaders regarding matters of significance to the organization.
•    Partner with Finance to manage the budget according to business expectations and commitments. 
•    Participate in the Concept to Commercialization (C2C) process as the GCO project lead and member of the project core team.  Responsible for the development and continued refinement of the clinical evidence generation plan and ultimately, execution of the finalized plan. 
•    Represent the GCO team during meetings with KOLs, management, FDA, and other global regulatory authorities, business, or functional groups.
Management of Direct Reports

•    Ensure GCO staff are trained in all applicable regulations, guidance, and Teleflex standards.
•    Participate in hiring, performance evaluations, termination, promotion, and merit decisions for multiple direct reports.
•    Drives setting of individual and team goals.  Monitors progress through milestones.  
•    Support team health activities to promote connectedness, growth, and development.
•    Manage external resources including consultants, vendors, and other external groups.

Department Infrastructure

•    Proactively provide solutions for process optimization through development of Standard Operating Procedures, guidelines, and departmental policies.  
•    Monitor emerging trends and review new or updated guidance documents to assess the impact to SOPs.  Integrate new requirements into department procedures. Maintain current knowledge of applicable US and international clinical regulations and guidance documents. 
•    Support EU MDR submissions through document updates and management of query resolutions.
•    Perform other duties as assigned.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
 

Education / Experience Requirements

•    Bachelor’s degree in a scientific or medical field; or equivalent experience.
•    Minimum of 8 years of experience successfully executing substantial clinical studies.
•    Minimum of 3 years managing direct reports.  
•    Medical device experience is preferred.
 

Specialized Skills / Other Requirements

•    Global clinical trial experience (outside the US) and post market study experience highly desired.
•    Strong knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
•    Ability to exercise critical thinking skills within a fast-paced environment.
•    Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.
•    Valid driver’s license issued by residing state and good driving record.
•    Ability and willingness to travel approximately 30% of the time.
•    Overnight travel will be required.  International travel may 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: Dallas
Nearest Secondary Market: Fort Worth