Director of Medical Affairs

Teleflex

About The Position

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™, LMA™, Pilling™, QuikClot™, 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 Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, 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 SummaryTeleflex 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.

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
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.

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!