Medical Science Lead - EMEA

The Patient Recovery Medical Affairs Department and the Cordis Medical Affairs Department both lead post-launch scientific and clinical activities, including grants, publications, evidence, relationships with medical stakeholders, Advisory Boards, clinical education, and overall clinical strategy. The team is uniquely positioned to deliver highly credible, scientific information to medical stakeholders (such as physicians and hospitals). The team will utilize cross-functional synergies between core competencies such as Medical Affairs, Clinical Operations, and HEOR offices to address scientific / economic needs arising from contemporary trends in the health care system.

We are looking for a scientific expert to develop peer-to-peer relationships using a professional data-driven approach to address scientific and economic needs of medical stakeholders. The Medical Science Lead (MSL) will bring a background of scientific and compliance rigor, and excellent communication skills. The MSL will be part of the Medical Affairs Department, and will report to the Patient Recovery Global Sr. Director and have indirect reporting to the Clinical-Regulatory team in EMEA. This person will cover the Patient Recovery portfolio for 50% of their time and the Cordis portfolio for the other 50% of their time.

Essential duties and responsibilities:

Develop and communicate in-depth clinical knowledge of the diseases of interest, including vascular thrombosis, nutritional insufficiency, coronary artery disease, and peripheral vascular disease Establish relationships with key opinion leaders, prominent academic and clinical investigators and leaders of medical and scientific organizations who can contribute to the clinical diagnosis and management of the diseases relating to the portfolio of products covered Educate healthcare professionals on the scientific safety and efficacy of data for the portfolio of products Support a scientific role in clinical trials, as necessary Identify and communicate key clinical and research insights from key opinion leaders to internal stakeholders to help formulate research and development strategies Participate in informing relevant investigators regarding pipeline and research opportunities Respond to unsolicited requests for investigator initiated studies (IISs) and support submission through appropriate internal channels Upon request provide support for reimbursement dossiers and tendering activities Upon request, provide support for medical affairs activities such as advisory boards, key congresses and society meetings Assist in the development and delivery of scientific training to field sales and other team members Collaborate with company’s medical safety functions (incl. Complaint Handling, Quality & Regulatory Affairs) in facilitating medical safety evaluations and decisions Establishes and maintains good and effective working relationships with the Medical Affairs Sr. Director, the Cordis Medical Director, the EMEA Clinical-Regulatory team, Clinical Managers and clinicians, scientists, core-labs, clinical consultants, and internal clients Key role in compliance & ethics, maintains good relationships with internal and external compliance partners. Ensures a professional clinical approach that is in compliance with the highest ethical and scientific standards for which patient safety and data accuracy are put first and considered as the highest goods Participates in the development and review of clinical reports, such as clinical evaluation reports, periodical clinical updates, clinical justifications for regulatory filings, and slide presentations pertaining to Company’s clinical material

Essential qualifications:

Technical skills:

Bachelors or above science / healthcare degree preferred and 3-5 years related medical device experience Excellent oral presentation and written communication skills Ability to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders Ability to initiate and maintain relationships throughout the medical community Demonstrated ability to build positive constructive relationships with cross-functional team members Demonstrated high level of personal integrity, emotional intelligence, flexibility Experience in relevant clinical practice preferred Understanding of the highly regulated medical device industry environment in which we work Ability and willingness to travel; 70% possible  Understanding of the EMEA legal and regulatory environment Clinical background, or extensive clinical research experience in the device or pharmaceutical industry Ability to assess clinical results summarize into reports, assist in authoring reports and justifications Experience in Operational processes, health care compliance, regulatory requirements, and project management is required Extensive knowledge of GCP, GLP, FDA, European Commission and MEDDEV regulations Understanding of clinical environment, patient care and cardiovascular procedures

Core skills:

Strong work ethic and commitment to serve internal and external clients. Energy, focus, motivation, debate-friendly, and good interpersonal skills Passion for science and teaching Open and honest approach to debates and constant evaluation   Team player, “can-do” attitude Ability and desire to develop good working relationships internally and externally

Education:

Bachelors or above science / healthcare degree preferred and 3-5 years related medical device experience

Other:

Excellent written and oral English communication skills

Ability to communicate in one or more additional languages used in Europe

  • Computer skills (PowerPoint, Word, Excel, Outlook, more) required