Director of Medical Affairs

Position Summary

Teleflex leaders use Leadership, Clinical Acumen, and Business Acumen to lead and develop their Clinical Medical Affairs team to consistently deliver high-value results and capabilities.  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 Director of Medical Affairs possesses strategic, managerial, scientific, and tactical skillsets to lead and drive activities under the umbrella of Clinical and Medical Affairs (CMA).  As an integral part of CMA, this role is responsible for oversight and development of a team, which works across the business teams to facilitate initiatives that foster and enhance the Company’s programs by continuously understanding, advocating, and driving actions on behalf of patients and customers.  The CMA team invests in leadership through a “just culture” approach of empathy, accountability, and humility.  The leader in this position will have experience in developing team members as part of that type of culture.  
The Director of Medical Affairs leads all aspects of the Medical Affairs work: 
•    Regulatory and Sustaining activities 
•    Scientific Analyses and Communications  
•    Clinical Evidence Strategy 
•    Product Safety support 
•    Clinical, Educational, and Promotional materials approvals  
The Director of Medical Affairs is responsible for leading complex, cross-functional projects within the Interventional Urology Business Unit, as well as the development and execution of the Medical Affairs function.  This position can influence and affect positive outcomes for patients.  This role requires creativity, flexibility, communication, and close collaboration with CMA, sales, marketing, legal, regulatory, and compliance functions. 

Principal Responsibilities

•    Organization Capability - Proactively manages performance and team dynamics to ensure that a fair, professional, and high-performance environment, aligned with company values, is maintained. 
•    Customer Experience –  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 and prioritize both process and performance gaps. 
•    Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant.  
•    In collaboration with CMA leadership, develop comprehensive evidence strategies by identifying clinical data needs of new products and unmet clinical needs of existing products. These plans will encompass study design and endpoints needed to meet clinical needs in medical practice, as well as the fulfillment of regulatory body requirements.   
•    Develop comprehensive publication and podium plans to amplify the clinical data generated by controlled clinical studies and real-world evidence.   
•    Provide congress support; answer questions at exhibits; develop and present clinical/medical content; staff medical booths; meet thought leaders; participate in customer events.   
•    Manage the physician liaison function relating to advanced and off-label product use of Teleflex products.  Lead the response to advanced or complex physician and patient inquiries, including but not limited to inquiries from patients, health care providers and administrators, payors, and scientific organizations.   
•    Oversee scientific and medical contributions to activities and deliverables, in particular giving input and insight on patient safety within clinical trials as well as in post-market activities.  
•    Approve sales training/marketing material content for fairness, balance, accuracy, and consistency. 
•    Lead and drive proactive and reactive customer interactions by collecting and sharing scientific knowledge and facilitating the development of physician and patient-facing materials. 
•    Develop and enhance interactions with key opinion leaders and societies. Develop relationships and cooperation with external experts and other important decision makers aligned with company strategies and objectives. 
•    Lead as a scientific and medical/clinical expert in activities and deliverables of the CMA organization, including but not limited to Medical and Clinical input and approval of technical files. 
•    Lead medical affairs support to sales, marketing, R&D, regulatory, and quality teams.
Execute the medical affairs strategy, identify new opportunities, collaborate, and communicate the medical affairs strategy and projects proactively. 
•    Lead a highly skilled Medical Affairs team, including hiring, developing, and motivating. Establish a culture of support, learning, efficiency, quality, and mentoring with high job satisfaction. 
•    Adhere to and ensure compliance with Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping standards. 
•    Collaborate and provide internal support to other areas of CMA, the business unit, and the company as requested. 
•    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 state, federal, Advamed, Eudamed, company, and industry organization policies with respect to physician interactions and related activities. 
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun! 

Education / Experience Requirements

•    Minimum 5 years of people management and development experience.
•    Minimum 12 years of experience in the Medical Device environment, providing strategic and scientific/medical direction to national/regional business unit functions required. 
•    Minimum 7 years of experience developing evidence strategies, publication plans, and clinical study protocols. 
•    Minimum 7 years of experience in developing clinical pathway strategies to meet global regulatory and clinical practice needs. 
•    Proven competency and experience (>3yrs) managing technical and clinical risk management, file review, and approvals from the Clinical/Medical perspective 
•    Experience in Advanced Practice, Clinical Management, or the Medical Device Industry for the management of urologic diseases  
•    Strong experience leading multiple projects involving complex issues and decision-making.  
•    Understanding of overall healthcare environment/landscape 

Specialized Skills / Other Requirements

•    Experience in the Medical Device/Biotech industry with a focus on Urology 
•    Strong computer skills, including MS Excel, Word, and PowerPoint 
•    Must have excellent interpersonal communication, including strong negotiation and persuasion, and strong presentation skills. 
•    Excel at building strong relationships both internally and in a heavily matrixed environment, and externally across diverse partnerships. 
•    Ability to work within the constraints of a regulated industry while achieving objectives 
•    Ability to define problems, collect, analyze, interpret, and summarize data, establish facts, and draw valid conclusions. 
•    Ability to identify priorities, meet deadlines, and work effectively in a fluid, demanding environment 
•    Ability to gain customer feedback, uncover business opportunities, and pair customer unmet needs with available internal resources. 
•    Willingness and ability to travel up to 30% as needed. 
Travel includes domestic and international travel, including overnight stays. 

TRAVEL REQUIRED: up to 30%

The pay range for this position at commencement of employment is expected to be between $175,800- $263,700; 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 a 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, the 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.