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Posted: Thursday, February 1, 2018 11:05 PM

**Job Summary:**
The Chief Medical Officer (CMO) will define and organize the core elements of clinical and medical affairs into a synergistic team. The goal is to build a scientifically robust and operationally efficient department that can help the company achieve its short and long-term goals. The position will directly oversee the functions of clinical research, scientific publications, medical information and medical safety. Additionally, the position will partner with quality, regulatory and product development to maximize their capacity and performance. The CMO will report directly to the CEO and serve as a member of the executive leadership team.
**Job Details:**
1. Lead and direct all Clinical Affairs activities, including the design and execution of a portfolio of pre- and post-approval clinical studies to bring new products to market and support their commercial growth, while ensuring speed, economy, and clinical excellence.
2. Work with R&D team in the early stages of product development to gather clinical input and assist in the construction of the VOC document.
3. Collaborate with regulatory in the preparation of investigation device exemption (IDE), premarket approval (PMA), 510(k) clearance and CE Mark submissions. Serve as medical expert in meetings with FDA and other health agencies.
4. Support the Quality Affairs organization during all FDA, Notified Body, and other agency audits and to provide medical leadership in support, inspections, NC/CAPAs, critical action committee (CAC) and other quality functions.
5. Direct the authorship of clinical study reports and subsequent publications and presentations of study outcomes. Ensure strong scientific presence at major medical conferences.
6. Maintain subject matter expertise through review of scientific literature, observation of medical practice trends and participation in industry meetings. Serve as clinical resource for management team, commercial organization and other internal stakeholders.
7. Orchestrate all aspects of medical information, including physician education, surgical mentor programs, medical science liaison (MSL) team, medical information requests and promotional review (PRC).
8. Strengthen engagement with medical community through various channels, including advisory boards, users meetings, CME programs, academic collaborations and professional societies.
9. Establish the systems, processes and personnel to ensure safety and performance of marketed products. Potential functions include: complaint investigation, medical review, adverse event reporting, trend analysis, health hazard evaluation (HHE) and clinical evaluation reports (CER).
10. Work with the Professional and Clinical Education (P.A.C.E.) team to design physician training programs and then support the delivery of those training events
11. Collaborate with leadership team & Business Development to evaluate growth opportunities based on unmet clinical needs, emerging technology, healthcare reimbursement and competitive landscape.
12. Provide leadership for the Grants & Donations Committee and ensure that all requests for support meet our mission in support of the advance of endovascular/minimally invasive procedures.
13. Lead the Field Medical Liaison organization. A group of 7 to 10 highly trained medical professionals that are responsible for providing medical guidance to our HCP customers.
14. Manage the Good Promotional Practices program and ensure that the delivery of off-label information is handled in a manner that follows all FDA and Governmental guidance.
15. Manage talent pipeline by recruiting, developing and rewarding high-performing employees.
16. Direct annual budget for department and safety programs.
**Qualifications** **Knowledge, Skills and Abilities (KSAs)**
+ Deep understanding of medical concepts and credibility as a clinical and scientific peer in interactions with KOLs.
+ Effectiveness in communicating complex scientific concepts to a variety of stakeholders.
+ Ability to advance projects and promote collaboration in a matrixed environment.
+ Agility and resourcefulness in response to unexpected challenges or dynamic situations.
+ Patience, fairness and loyalty in interactions with colleagues.
+ Ability to make difficult, high-stakes decisions and provide credible leadership.
+ Willingness to travel extensively and work long hours as needed.
**Background Experience:**
+ MD with 10+ years of clinical practice. Strongly prefer experience with surgical procedures and surgical decision-making.
+ Medical device or pharmaceutical industry experience with 7+ years of well-rounded exposure to clinical research, medical affairs and materiovigilance.
**Title** Chief Medical Officer
**Auto req ID** 4958BR
Affirmative Action/Equal Employment Opportunity Statement
It is the Company's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-###-#### or e-mail us at ...@Terumomedical.com.
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

Source: http://www.jobs2careers.com/click.php?id=4846566115.96


• Location: Jersey Shore, Somerset

• Post ID: 53454542 jerseyshore
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