Medical Monitor Director
Milestone Pharmaceuticals is an equal opportunity employer. This position will be in Charlotte, NC.
The Medical Monitor Director will lead, plan and coordinate the strategic objectives of the Clinical Trials ensuring compliance with regulatory and ethical requirements. This role will have leadership in the oversight and tactical execution of all the activities of the clinical trials, will monitor the data, and will contribute to advancing projects aligned with the Company’s short- and long-term strategy.
Main Duties and Responsibilities
- Represents, leads, plans and coordinates the strategic objectives and tactical execution of the clinical investigation, ensuring compliance with regulatory and ethical requirements;
- Ensures high quality in the design, development, execution, statistical analysis, interpretation and reporting of clinical studies, and ensures studies are continuously inspection ready;
- Monitors the data generated by CROs involved in the Clinical Research projects;
- Provides medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, concomitant medications and general medical-related study issues;
- Reviews laboratory alerts, and coordinates appropriate follow-up with study site;
- Conducts medical review of the SAP, project plan, tables and listings and clinical study reports;
- Conducts training for the project team regarding the disease, drug, study design and procedures;
- Provides consultation to the study team during review of out-of-range laboratory values for clinical and/or protocol significance;
- Previews listings, lab reports and subject profiles; ensures all protocol inquiries are documented;
- Visits sites, and attends and participates in Investigator meetings; and
- Reviews study reports, prepares and reviews subject narratives as well as periodic safety
Education, background, knowledge and skills
- MD is required—Cardiology specialization preferred;
- At least five (5) years of clinical development expertise and deep understanding of the process to progress a new chemical through the necessary stages to allow testing in human clinical trials;
- Good Clinical Practice (GCP) knowledge—able to ensure an investigation is conducted according to GCP regulation and documentation to protect the rights, safety and well-being of the subjects;
- A record of applying medical expertise to make good clinical decisions in accordance with SOPs;
- Demonstrated understanding of rigorous data generation and disciplined stewardship of the data;
- Medical monitoring and pharmacovigilance expertise to detect, investigate, assess and prevent adverse effects of medicines on patients; and
- Excellence in scientific writing and presentation to produce publications with clarity, accuracy and rigor, and to communicate concepts simply and concisely to diverse audiences.
- An ethical, resourceful, confident physician with deep clinical research experience and knowledge, as well as proven leadership abilities;
- A strategic thinker who ensures the application of principles, tools and systems from Simplifying Clinical Development;
- Exceptional verbal and written communication abilities;
- A natural partner with high standards and capability to firmly advocate for them; and
- Excellent teamwork and interpersonal skills, and high emotional
Milestone Pharmaceuticals is a developmental pharmaceutical company which is developing novel small molecule therapeutics for transient cardiovascular conditions. Milestone offers an exciting and entrepreneurial environment, and a competitive compensation and benefits package.