The Director of Medical Information partners with stakeholders and cross-functional partners to successfully develop and monitor Aadi’s Medical Information strategy and objectives.
The Director of Medical Information drives the development, implementation, and execution of Medical Information content and services.
They also serve as a member of the medical and promotional review committees (MRC and PRC).
Specific responsibilities include building the Medical Information services function and team, developing medical content for healthcare professionals and consumers, and oversight of vendor services along with implementing and tracking KPIs and metrics.PRIMARY JOB FUNCTIONSStrategic development, implementation, and execution of Medical Information content and services, including the development of an overall strategic and operational plan with the vendor responsible for the Medical Information call centerManagement, training and supervision of Medical Information staff including call center, contractors, vendors/agenciesDevelop and manage the Medical Information budget and liaise with financial / project management for budget planning and trackingDevelop and oversee the generation of timely, accurate, thorough and balanced responses to unsolicited requests for information about products from healthcare professionals and consumers consistent with regulatory guidelines utilizing appropriate information resourcesEnsure adverse events and product quality complaints are processed in accordance with company SOPsDevelop and update Medical Information standard responses, FAQs and medical library with new publications, congress data, and clinical trial informationProvide medical information trend reports, presentations, and information to cross-functional partners and Senior Management as appropriateRepresent Aadi at local, regional, and national congresses and meetings as necessaryParticipate as SME ad hoc on cross-functional committeesResponsible for providing medical input to the MRC and PRCProvide input into policies and procedures to ensure regulatory compliance for the provision of Medical Information services to healthcare professionals and consumers, collaborating cross-functionally to align appropriate corresponding SOP(s)/guidance(s)Provide input into the AMCP dossier development and lead all updatesResponsible for the clinical compendia strategy and submissionAdvanced scientific degree required6+ years of experience in the life science industry (e.G., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health, including 3+ years in Oncology and medical information/medical communication experience.Excellent communication, presentation and time management skills requiredExperience with FDA audits is highly preferredExperience launching novel biotech/pharmaceutical therapies is highly preferredCurrent deep knowledge of US legal, regulatory, and compliance regulation guidelinesDemonstrated leadership in ambiguous situationsAbility to partner with key internal and external stakeholders to understand key objectives and to drive plans that achieve or exceed these objectivesMust be adaptable and able to work well within a team and relate effectively with people at all levels of the organizationComfortable in a fast-paced small company environment and able to adjust workload based upon changing prioritiesOTHER REQUIREMENTSThis role can be performed remotely from a home office in the US