The Medical Scientific Liaison (MSL) provides non-promotional, medical support that helps to ensure the safe and effective use of Aerogen’s devices, through effective scientific interactions with external experts, to provide support to clinical development colleagues in site selection and with investigators conducting Aerogen clinical trials, and to provide scientific support for Aerogen internal stakeholders (Sales, Marketing, R and D, and Clinical). The MSL is the field-based scientific expert on their assigned therapy area, disease area, clinical practice and competitor landscape. Through their expertise and external interactions they will develop insights which will assist in the development and execution of innovative strategies and plans that clearly support development of devices of value for patients and customers. The language and activities of MSLs must at all times reflect the medical nature of their role, be fair, balanced, non-promotional, scientific and evidence-based. MSL must ensure full compliance with Aerogen SOPs and local laws and regulations for all country medical and promotional activities. The MSL brings value, protects Aerogen’s reputation, and builds trust by providing scientifically accurate, fair- balanced, on-label information, regarding the safety and efficacy of Aerogen products and off- label information in response to unsolicited questions.
Duties / Responsibilities
- Interaction with Key Opinion Leaders:
- Provide fair and balanced information on the benefits and risks of products, therapeutic option and disease state.
- Obtain feedback and advice about company products or pipeline through peer-to-peer interactions and advisory boards and communicate relevant information back to internal stakeholders.
- Facilitates initiation, development, and ongoing maintenance of centers of excellence, and programs to develop speakers from these centers to support broader education needs.
- Train and develop speakers on the company’s products and manage the related speaking engagement schedules
- Successfully connect opinion leaders globally or locally to serve as advisors, investigators, expert guest speakers, or business development partners
- Support Research Endeavors:
- Gather competitive intelligence and report back to Aerogen
- Receive internal training by expert external guests and internal colleagues
- Provide synopsis of information presented to internal colleagues
- Work closely with the commercial function to provide marketing and sales with the clinical and scientific data and background support that they need to grow Aerogen’s market share.
- Facilitate research and reports of on label use of products demonstrating cost benefits, LOS, and other outcomes.
- Increase knowledge in the community of product of pipeline research activities
- Maintain Scientific Expertise of Products and Disease States
- Keep abreast of cutting edge research and literature in therapeutic area
- Attend scientific meetings and symposia
- Managing Aerogen’s clinical trials in Europe and rest of world (including identifying strong trial centres, agreeing protocols and contracts with investigators, ensuring studies stay on track, helping to draft abstracts and manuscripts and ensuring fast publication in the right journals).
- Act as a conduit for unsolicited, investigator-initiated research proposals by facilitation proposal, advise on the mechanics of the application guidance, and act as a conduit to senior management, for the publication of studies
- Provide Scientific Information and Education Support:
- Discuss disease state or product information through peer-to-peer interactions with opinion leaders for -on label use
- Answer questions on appropriate off-label information in response to unsolicited questions
- Recommend, recruit and train participants for speaker bureau providing support with informational needs of speaker and faculty
- Deliver presentations to the health care community and purchasing/formulary decision makers
- Support medical or scientific activities at conferences or meetings
- Conduct medical educational training for internal partners.
- Provides scientific support to commercial and Medical Affairs partners, including training, medical writing, education and other scientific projects
- Regularly collects and interprets medical insights and feedback gathered from scientific exchange with opinion leaders and communicates relevant information to internal stakeholders in order to define, update, and support medical strategies.
- Support connections to external research community:
- Manage Aerogen’s engagement with clinicians and academics conducting research into applications of Aerogen technology:
- Facilitate the initiation of investigator initiated studies with Aerogen technology.
- participate in the assessment of clinical evaluation protocols;
- determine and negotiate appropriate mechanisms to provide equipment or other forms of support;
- administer study documentation, including research and supply agreements, insurances and liability issues, and submissions to IRB etc.;
- monitor compliance with regulatory guidelines in investigations of off-label usage;
- support and encourage the publication of study outcomes in the peer reviewed literature;
- Evaluate, design and co-ordinate opportunities for post market clinical studies on current Aerogen products.
- Provide clinical input to the regulatory affairs department in the preparation of regulatory submissions and product registrations.
- Provide clinical support to manufacturing and quality for sustaining commercial products; e.g. resolution of quality concerns, evaluation of customer complaints.
- Provide clinical presentations and medical information to managed markets and government accounts when requested.
- Complete all required training, documentation, expense reporting and other administrative responsibilities.
- Ensure compliance with all regulatory and Aerogen Requirements.
- Travel will be required for this position and will equate to 30 – 60% of the individual’s time. Person applying for this position would need to reside within geography in support of area customer initiatives. It would be advantageous to live within 50 miles of an airport and candidates near Dublin or a UK based airport would be considered. Candidates not based in Galway should expect to spend at least 6 days a month in the Galway office.
- Changing priorities; long hours occasionally required to complete projects. Handle multiple projects with tight deadlines. Work after hours is occasionally required to complete work tasks and meet deadlines.
- Typical office environments, with work also performed in Science labs, and hospital clinical environment.
- The role will involve a frequent domestic and limited international travel.
- Life Sciences degree, PhDf, MD or Pharm D with a Medical / Clinical Focus.
- Clinical experience with aerosol therapy, critical care, and/or respiratory care.
- At least 5-7 years, hands-on, relevant medical device/pharmaceutical and clinical experience
- Evidence of Clinical knowledge/experience. Sufficient depth of knowledge and expertise in specialist area of research
- Recruitment and negotiation of clinical trial sites
- Ability to work independently within the context of multidisciplinary external and internal teams
- Ability to assess and organize resources, take organized approach to handling a busy workload
- Must possess the ability to resolve issues in an organizational and analytical manner.
- Creativity and innovative flair.
- Attention to detail in creation and examination of clinical and scientific documentation.
- Ability to be conversant with analytical models and correlate experimental to theoretical results.
- Excellent presentation skills. Ability to clearly and convincingly communicate new ideas, concepts, issues and successes.
- Highly effective interpersonal skills and the ability to continually demonstrate poise, tact, and diplomacy are necessary
- Good command of written and spoken English
- Good computer skills. Experienced with Microsoft Office applications for generating office documents, spreadsheets, project plans, etc.
Education / Experience
- German and/or French as a second language
- Clinical experience in situations where direct/or indirect decision making authority for patient care was demonstrated (e.g. direct patient care, treatment protocol development, therapy guidelines development, traditional clinical practice settings) or medical liaison experience
- Experience in monitoring clinical trials
- Conversant with Good Clinical Practices and associated international requirements
- Scientific publication in internationally recognized peer reviewed journals
- Selection and negotiation with Clinical Research Organizations
- Human studies design and execution
- Understanding requirements for Clinical Registry
- Presentations at national and international conferences
- Assisted in writing, submission and subsequent publication of peer reviewed scientific manuscripts.
Closing Date for Application
Closing Date 7th April 2017
Aerogen is the world’s leading medical device company specialising in the design, manufacture and commercialisation of aerosol drug delivery systems.
Founded in Galway, Ireland in 1997, we have grown to become the global leader in high performance aerosol drug delivery, partnering our technology with the leading mechanical ventilation companies.
Aerogen technology is used by millions of patients and caregivers in over 75 countries worldwide.
To find out more go to www.aerogen.com
Some of the benefits our employees enjoy at Aerogen:
- VHI including Dental
- On-site Free Parking
- Paid Holidays
- Sports & Social Club