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Director Medical Affairs, Enabling Technologies

Medical Affairs
19000B47 Requisition #
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Careers that Change Lives

A Day in the Life

Provides overall strategic direction for all Clinical, Medical Affairs and evidence generation activities in support of the introduction and market acceptance of Enabling Technologies products.  This includes overall global portfolio direction for the design and implementation of all clinical, post-approval and real-world evidence studies, clinical safety, and scientific communications activities. This position provides leadership, oversight and guidance to the Global Clinical and Medical Affairs team across Enabling Technologies and is responsible for developing a global high-performance organization through hiring, developing, and promoting key individuals to meet and exceed organizational needs.  Provide clinical and medical input to new product development process.

Position Responsibilities

·      Establishes and communicates strategic objectives and operating plan for the Clinical and Medical Affairs function across Enabling Technologies, overseeing Clinical Sciences / Strategy, Scientific Communications / CER, ERP Management, Office of Medical Affairs and Product Safety functional capabilities to ensure strong strategic execution.

·      Creates and communicates evidence generation strategies to achieve clinical and economic outcomes for Enabling Technologies portfolio

·      Ensures Medical Affairs strategic plans are aligned with business divisional objectives to offer Healthcare Professionals with safe and effective products

·      Partners closely with Brain Therapies Clinical Operations Leadership to ensure Enabling Technologies Medical Affairs strategy is understood and that studies / trials are properly executed within strategic framework

·      Partners closely with clinical and medical affairs leadership in disease state partners such as Spine and Brain Modulation

·      Participates as a member of the Enabling Technologies Leadership Team to establish strategic plan and direction for the company. Informs the team through regular reporting the anticipated impact on products because of clinical activities and findings

·      Maintains strong understanding of product knowledge, relevant anatomy, and accepted applications and uses associated with our products

·      Maintains understanding of competitive offering and value propositions in Enabling Technologies and adjacent spaces

·      Provides guidance and technical expertise to assure that all necessary clinical affairs activities are always in governmental and quality compliance, including, but not limited to ISO 9001, FDA regulations, and QSR (GMP) standards

·      Oversees post market registry and maintains compliance and direction of site selection and investigators for clinical trials

·      Ensures the creation and effective articulation objective value propositions for Enabling Technologies products

·      Oversees presentation and publication strategy of clinical trial data

·      Provides clinical and medical input to the new product development process

·      Directs all necessary human and capital resources to accomplish division strategic and operating plan

·      Develops capital and expense budgets, tracks expenses and takes action to correct deviations from plan

·      Provide direction and oversight to implement corporate compliance of third party policies and procedures in accordance with laws and regulations of this and other countries, securing professional legal counsel when necessary, as it relates to education programs and funding policies

·      Ensures cross-functional alignment with respect to Enabling Technologies’ relationship with and support of key surgical associations, societies, KOLs, healthcare professionals

·      Support Clinical and Medical Affairs advisory board meetings and activities across Medical Devices.

Must Have: Minimum Requirements

Bachelors Degree
10+ years direct clinical trial management experience or related health care experience.
7+ years in a strategic leadership position is required; or a combination of education and experience providing equivalent knowledge.
Working knowledge of FDA and ISO regulations.
Experience in conducting clinical studies both domestically and internationally.
Proven ability to develop and execute long range strategies to achieve competitive advantage and translate strategies into specific objectives and operational plans.
Proven effective leadership skills to provide overall direction and assign authority and accountability of all clinical affairs and adapt approach to match the needs of different individuals and teams.
Effective leadership and team facilitation skills to motivate engineers, marketing, regulatory and clinical staff to deliver information related to submission preparation and/or direct or participate technical and sales marketing product literature review.
Demonstrated ability to guide, mentor, and develop staff members and successors to key positions within the division.
Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills. Proven ability to cultivate an active network of relationships within and outside of the organization.
Sound financial knowledge and experience to understand key financial indicators for the division as well as the company and to evaluate strategic opportunities.
Seasoned judgment to address and resolve critical issues and make timely, complex decisions.
Develops short and long term strategic and operating plan for entire Medical Affairs functional area.
Microsoft Word, Power Point, and Excel are required

Nice to Have

Medical degree or PhD preferred
Real World Evidence experience preferred
Self-directed demonstrating high degree of initiative
Excellent planning and organizational skills
Strong communication, presentation, and technical skills
Ability to communicate complex information in a clear, concise manner.
Good interpersonal skills to relate well with various business contacts.
Operate within budgetary limits.
Able to make sound business decisions.
Competencies: Integrity and trust, drive for results, building effective teams, action oriented, business acumen, interpersonal savvy, dealing with ambiguity, managing diversity
Other Skills: Excellent strategic ability, creative thinker. Good interpersonal skills and understanding of surgical procedures and clinical needs

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)

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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