The Medical Director/Medical Monitor is accountable for providing medical and scientific expertise and oversight for clinical trials and serves as the point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.

Responsibilities

• Lead all scientific aspects of conceptualizing and planning clinical trials, including ensuring cross-functional integration, co-ordination and alignment to enable efficient clinical development plans, study designs and study protocol
• Serve as the Medical representative on clinical teams and provide medical expertise and leadership to projects
• Serve as the Medical representative on clinical teams and provide medical expertise and leadership to projects
• Contribute to clinical trial documents including protocol, ICF, study plans and SAP
• Oversee medical activities conducted by CROs, including review of medical coding and deviations
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports and conduct benefit-risk assessments on clinical candidates
• Contribute to clinical study reports and ensure the medical and scientific validity of study report, especially conclusions regarding efficacy and safety.
• Author clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections) and support clinical regulatory authority actions
• Prepare scientific and clinical data for presentations to senior management, scientific conferences, clinical study investigator meetings, and clinical advisory boards
• Support development and execution of a publication strategy in collaboration with other functions
• Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community
• Serve as a scientific and clinical resource within Adagio, including provision of scientific and clinical guidance to other relevant functions

Qualifications and Experience

• Four (4)+ years relevant experience with proven track record designing and executing clinical trials (Phase 1 – Phase 3), preferably in industry environment (pharmaceutical industry, biotech)
• Knowledge of clinical trial methodology and development process, regulatory requirements governing clinical trials.
• Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects
• Ability to motivate, influence and collaborate with others across all levels of the organization.
• Excellent written and oral communication skills
• Ability to engage internal and external experts in constructive scientific dialog around study design, conduct and data interpretation
• Ability to travel domestically and internationally

Education

• MD (or non-US equivalent degree) with training in Internal Medicine/Infectious Diseases or Pulmonary/Critical Care preferred
• Specialty/subspecialty board certification preferred LESS…