Director of Clinical CV/NM
St. Jude Medical - Saint Paul, MN

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Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn''t this the kind of change you would like in your life?
We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our International Sales Division located in St. Paul, MN:

Job Overview
The International Division Director, Clinical Studies is responsible for partnering with International Clinical, Marketing teams along with Product Division Clinical and Marketing teams to develop and execute strategic plans which support International business growth goals. This includes setting direction for pre-market and post market clinical projects to support scientific publications, regulatory and reimbursement applications, new product launches, health economics evidence, therapy acceptance and adoption.

• Direct Clinical Strategy through:
o Collaboration with Product Division, Geography and country stakeholders
o Direct the development, implementation and management of clinical protocols, investigational plans, submissions and clinical trial agreements
o Remain current on developments in field(s) of expertise, regulatory requirements, as well as industry trends.
o Solicit, develop, assimilate, and disseminate data regarding emerging and evolving indications, methods , and SJM technologies This includes driving publication strategies abstract presentation at scientific symposia, or internal white paper.
o Consultation to development of technical memoranda, and related documents. Provide consultation to project teams as needed for clinical issues.
o Oversee clinical input to project teams including risk analysis documentation, clinical evidence summaries, clinical use,and evidence generation required for reimbursement and market acceptance.
o Create new relationships and collaboration with existing KOLs for international clinical and marketing initiatives
o Collaborate with ID Marketing and ID Reimbursement to assure effective clinical investigations and product launches
o Lead and participate in product strategy roundtables and other Physician Round Tables type meetings, Key Opinion Leader mapping and strategy development
o Establish customer and/or site recruitment plan
•Support commercial strategy development:
oStrengthen and guide Clinical Marketing; i.e. marketing and promotion of SJM clinical projects and results
oAdvise geographies on publication strategy to support marketing goals
oPartner with Geographies to maximize Academic Center/Emerging KOL programs, initiatives and strategies
oDevelop and review literature/documents/materials and select and/or summarize such for distribution in support of marketing initiatives
oRecognize, evaluate and take action on out of scope activities
•Serve as senior customer facing SJM representative to customers
oRepresent SJM at external meetings such as congresses, investigator meetings, scientific association meetings including conducting scientific/medical presentations
oInteract and consult with physicians, scientific societies (e.g. ESC, EHRA) and other appropriate personnel in the health services and health delivery industries, government, health policy organizations and with appropriate university, corporate, and governmental medical research personnel.
oInteract with internal and external teams to support commercial strategies
oSupport Government Affairs activities to improve therapy access, reimbursement and regulatory policy
•Support and coordinate International Clinical Investigation
oExecute project management tasks for international projects
oReport activities on respective franchises projects
•Support Product Division strategy and tactics
oProvide consult and support for customer communication on SJM product performance, product issues, FERs
oSupport Business Development evaluations, technology assessments and other due diligence activities
oPartner with Product Development and International clinical teams to monitor patient safety on-site address protocol violations
•A minimum of ten plus years of progressively responsible relevant clinical, regulatory, and/or broad medical research experience
•Demonstrated background and practical experience advising the design and implementation of pre and post market clinical trials Demonstrated background in partnering with upstream and downstream marketing teams to identify, develop, and commercialize best in class medical device products
•Strong verbal and written communication skills, interpersonal skills, and analytical skills
•Proven ability to work autonomously and as part of a team
•Thorough understanding of International regulatory standards
•Previous experience presenting at medical congresses and/or symposiums
•Previous experience advising international medical device marketing and clinical teams
•Multi-lingual written and verbal fluency
40% international travel is typical. Up to 60% travel at times is likely based on domestic and international travel combined
Position requires sitting for extended periods of time, walking, traveling globally via plane, car and train, placing and accepting calls in morning and evenings to accommodate international office working hours, and light lifting.

St. Jude Medical - 2 years ago - save job
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