The Field Medical Affairs Liaison is a scientific resource capable of conducting high level scientific and strategic interactions across product and disease states with external thought leaders as well as internal Achaogen stakeholders. The Medical Liaison for the North Eastern Region will foster close relationships with key external stakeholders through innovative means of scientific engagement. The FMAD will assist with relevant Phase IV clinical trials, other clinical studies and investigations, develop and cultivate strong relationships with the local, external scientific and medical communities in alignment with scientific product strategies thorough an understanding of healthcare delivery and clinical and quality metrics. The medical liaison will also conduct healthcare professional education, participate in clinical and scientific meetings and presentations, seek feedback and input from external experts on Medical Affairs-generated topics, respond to unsolicited questions regarding Achaogen’s products, and provide clinical input into Achaogen’s communications and materials. The FMAD is responsible for supporting medical education, training, clinical/non-clinical research, and health economics activities for both marketed and pipeline products. The FMAD should have a deep knowledge of the scientific trends within the infectious diseases and acute care environment and be able to effectively synthesize and communicate scientific field insights to internal stakeholders (e.g., Medical Affairs, Senior Management, Investor Relations, Clinical Research, Business Development).
- Maintains the highest standards and levels of scientific, clinical and technical expertise in infectious diseases and acute care environment; reviewing and keeping updated on scientific/medical journals and other relevant publications, attending scientific, clinical, commercial and other key meetings, forums, venues, etc.
- Identifies, establishes, develops, and maintains relationships with the local scientific and medical communities, regional thought leaders and other healthcare professionals and provides fair balanced medical information at all times.
- Works with manager, peers, other partners and stakeholders in the development and alignment of medical plan tactics at the regional and local Medical Affairs levels:
- Provides insights from the field to drive innovative programs throughout Medical Affairs.
- Participates in a variety of cross-functional tactical planning meetings, reviews and discussions.
- Supports his/her manager, medical directors, and other peers in gathering information, analyses, research and reporting to support national, regional, and local tactical planning.
- Provides input to manager regarding travel, budget and other resource requirements to meet or exceed assigned goals and objectives.
- Support data generation and external research in alignment with strategy, including HEOR data on Achaogen marketed products and relevant disease state and burden of illness issues.
- Builds, cultivates relationships, and supports internal cross-functional partners, such as Sales and Marketing, Clinical Research, Regulatory Affairs, Microbiology, Research and Early Development, Business Development, Clinical Operations and other Medical Affairs and Commercial Operations groups.
- Works with a host of cross-functional partners to develop plans and tactics for implementation and completion of clinical trials, studies and other investigations.
- Supports design and development of clinical trials, other studies and investigations, including plans for developing and recruiting patient registries.
- Evaluates, reviews and proposes, when and where appropriate, revisions to protocols in support of the development and/or medical strategies of the assigned product(s). As and when approved, undertakes the necessary revisions to protocols, ensuring full compliance with all established procedures and guidelines, as well as appropriate communication to other involved/impacted colleagues and/or external parties.
- Builds and cultivates relationships with study site clinical research staff, clinical investigators, physicians, pharmacists, microbiologists, etc. This includes supporting Clinical Operations with Phase III studies.
- Works with Medical Communications and Publication Planning to develop, disseminate and manage calendars and timelines for clinical and scientific communications, publication plans and other relevant research, data, information and communications.
- Contributes to clinical and scientific communications, publications, clinical and scientific education, advisory boards, clinical and scientific congresses, other conferences and meetings, etc.
- Contributes to competitive intelligence gathering and summaries of information from important medical conferences.
- Supports the development of other medical science liaisons through mentoring.
- 4 or more years' related work experience (academic, research, clinician, consulting or industry experience).
- Previous experience as a field medical science liaison is a plus.
- 2 years or more clinical trial experience (either in industry or in another, related setting) is preferred.
- 2 years' experience in infectious diseases or acute care environment.
- Advanced Clinical/Science Degree is preferred (e.g., MD, PharmD, PhD, MSN, MPH, etc.).
Preferred Additional Skills:
- An in-depth understanding of Phase IV/post-marketing drug development is preferred (knowledge of or experience with Phase I - III drug development is a plus).
- GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient .
- Comprehensive understanding of product and safety profiles.
- Demonstrable knowledge of medical aspects of FDA regulations.
- Strong communication, presentation and business partnering ability.
- Demonstrated ability to build strong customer relationships.
- Able to effectively handle multiple tasks and priorities in a fast paced environment.
- Strong interpersonal skills and ability to work with others in a positive, collaborative manner.
- Ability to work well on cross-functional basis internally and with business partners.
- Proficient computer skills, including Microsoft Word, PowerPoint, and Excel.
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
- Current US work authorization required.
- Ability to travel domestically and internationally.