The Director Medical Information will be responsible for the strategic direction and oversight for communicating scientific and medical information to healthcare professionals, patients, and other stakeholders in response to unsolicited requests for information in an accurate, consistent, compliant, and timely manner. The role also encompasses management of Achaogen data in third party drug compendia, review and approval of promotional materials, and support of the development of product dossiers and a company bibliography. In addition, the individual serves as a member of the Medical Affairs Leadership Team.
Develop and oversee the process for the receipt and resolution of medical inquiries, adverse events, and product complaints from healthcare professionals, patients, and other stakeholders. This will entail the management of an external call center contract organization that will provide first line, call center services.
Develop and maintain Standard Response Letters to enable efficient and consistent responses to requests.
Develop custom responses as needed to respond to requests in a comprehensive and compliant manner.
Coordinate, create and/or review submissions to external compendia and drug information resources.
Ensure appropriate staffing support for Medical Information booths at key scientific congresses.
Manage Medical Affairs participation in the review of promotional materials.
Support the development of product dossiers.
Maintain an accurate and up to date bibliography and reference library of clinical and non-clinical data related to Achaogen’s products.
Develop and manage team members, including hiring, talent management, succession planning and performance management.
Ensure training and development of team members, and work to identify and provide formal and informal training for other stakeholders for other stakeholders regarding Medical Information processes and compliance.
Forecast and propose resource allocation plans as well as manage resources within budget.
Establish collaborative working relationships with functions outside of MA including, but not limited to: Clinical Development; Regulatory Affairs; HR; Legal; Drug Safety; and Commercial to optimize the financial, technical, compliance, and strategic management of key functional areas.
Minimum 8 years of relevant experience in a corporate setting with an emphasis on Medical Information.
An in-depth understanding of the principles of fair and balanced response to unsolicited inquiries.
A firm understanding of infectious disease including microbiology, PK/PD, and therapeutic drug management.
Advanced degree such as PharmD or MD with experience in Infectious Disease.
Preferred Additional Skills:
Strong communication, presentation and business partnering ability.
Excellent written and verbal communication skills.
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.
Proficient computer skills, including Microsoft Word, PowerPoint, and Excel.
Proficient in various communication / collaboration platforms including Gmail, Google Calendar, Slack, Hangout, Box, Google Docs and SharePoint.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Current US work authorization required.
Ability to travel domestically and internationally.
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. We are anchored by our key values of integrity, accountability, transparency, scientific rigor and drive. We pride ourselves in creating a work community that is scientifically driven, supp...ortive, and collaborative. We encourage the diversity of thought that leads to great innovation and are looking to add to our dynamic team with people who are driven to transform the lives of patients.