Chief Medical Officer, Senior Medical Affairs Director

Company: Medtronic GmbH
Location: Sunnyvale
Posted on: February 23, 2021

Job Description:

Chief Medical Officer, Senior Medical Affairs Director This position--will--provide--thought leadership, objective medical oversight, guidance, and expertise to the Gastrointestinal Operating Unit (OU) leadership team.--This--position--will--support--the OU in advancing our capability to treat unmet patient needs through diagnostic and therapeutic technologies.--The--position--will work--with--the--Medical Safety--team--to--support--Quality,--Regulatory,--Research--&--Development,--and--Clinical activities. This position reports into the President, Gastrointestinal and is a member of the GI OU leadership team. In addition, this position will work with the other CMOs across MDT in providing leadership on medical safety and scientific affairs.
A Day in the Life

• Provide strategic guidance on evidence development, clinical communications/publications and training and support needs in the field
• Serve as GI medical representative at major congresses, advisory board meetings, and other key industry panels and events involving key opinion leaders
• Builds and maintains relationships within the medical community to assess emerging medical and healthcare practices in the GI space
• Support the GI LT with medical expertise and contribute to the overall corporate strategy
• Lead with the OU president executive presentations with the ExCom
• Identify and establish relationships with leading KOL's and principal investigators, including--organizing and running KOL meetings and Advisory Boards, as needed
• In partnership with the GI Clinical organization, provide leadership in medical expertise for clinical trials
• Contribute to the development of regulatory strategy and act as the medical expert in meetings with regulatory authorities
• Ensure and support effective leadership and seamless collaboration across all areas of research
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
• Represent the Company and its programs to external audiences, including investors, medical and regulatory communities, as well as distribution's partners
• The CMO will have direct line responsibility for, Patient Advocacy and Global KOLs expansion with particular focus on China and Japan
• Consult on theoretical and experimental scientific and technological investigations for advancements or new discoveries
• Serve as a medical consultant to marketing, commercial, or research program teams and government regulatory agencies
• Partner with Sales and Marketing to develop key messaging and identify and capitalize on current and future business opportunities based on changes in the medical and regulatory environment.
• Consult and provide design input on new and next generation procedural and product design with R&D
• Partner with business development in providing market, patient population, and physician practice assessments and evaluating external opportunities technically and clinically
• Provide medical expertise and objective safety oversight to ensure patient safety throughout the product lifecycle, including product development processes, risk management, clinical trials, post-market safety surveillance, and field actions
• Collaborate with the quality function to add clinical perspective to quality issues including ensuring global product quality and patient safety, provide clinical input to pre- and post-market risk management judgments, interpret complaints/comments, educate the organization on quality metrics and outcomes in emerging fields, work with engineers on performance metrics and co-facilitate the Independent Physician Quality Panel (IPQP)
• Provide medical review and assessment of critical safety issues impacting the BU, and recommend action, as needed
• In conjunction with the--Medical--Safety--Specialists,--review--and--provide--input--to--issue--impact--assessment (IIAs),--risk--assessments,--signal--investigations,--and--field--action--assessments--within--the--business
• Provide--medical safety--input--and clinical guidance for--clinical--trial--strategies
• Work--closely--with--the--Medical Safety--Specialist(s) and--serve--as--a--resource--for the--Medical--Safety--Specialist(s),--as--needed, to provide--input--on--difficult--or--unclear--cases
• Interact--with--the--global functional leaders--of--Medical--Safety,--Quality,--Regulatory,--and--Clinical--senior management concerning significant--patient--safety--issues for the--OU
• Collaborate--with--other--Medical--Directors--and--Medical Safety--leaders across--Medtronic to--share--best--practices
• Interface--with--the--regulatory--agencies (domestically--and--internationally),--as--needed
• Mentor,--coach--and--teach--others in--the--business unit--on--appropriate application--of--laws--and--standards in--the--areas--of--patient safety--and--safety--data--analyses Must Have: Minimum Requirements
  • Minimum of 15 years of relevant clinical experience with 10+ years of managerial experience , or Advanced Degree with a minimum 13 years prior relevant clinical experience, minimum of 10 years of managerial experience
  • Medical Doctor (MD/DO) or equivalent degree
  • 5+ years of patient care experience beyond residency Desired: Preferred Qualifications
    • Life sciences industry experience - knowledge of clinical trial management, quality systems, global regulatory experience
    • Advanced degree such as MBA, MMM, MHA, MPH
    • Proven analytical skills working with clinical or research data
    • Knowledge of patient safety, quality, clinical research, strategic planning, health biostatistics or epidemiology
    • Strong "influence management" skill set demonstrated in both the healthcare delivery and corporate environment
    • Demonstrated success in effectively managing teams, executing on projects, and communicating expectations
    • Demonstrated ability to lead collaboratively in a diverse, global, matrixed organization.
    • Knowledgeable of U.S. Food and Drug Law and regulatory, device safety and/or regulatory/clinical research
    • Experience interacting with FDA or other regulatory agencies About Medtronic
      
      Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
      
      We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
      
      Physical Job Requirements
      
      The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Sunnyvale , Chief Medical Officer, Senior Medical Affairs Director, Healthcare , Sunnyvale, California