In collaboration with the Clinical Development Lead, as well as other program functional area leaders, the Medical Director will support the clinical development program teams responsible for study design, development, execution, data readout, and summary. This position will also provide ongoing input into assessment and interpretation of safety data and contribute to investigator training. This is a remote-based position.
· Providing medical/clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical development, and clinical operations.
· Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
· Collaborates with external opinion leaders and Principal Investigators, as well as internal clinicians, clinical scientists, translational scientists, and clinical operations personnel to ensure appropriately designed studies are successfully implemented.
· Serve as Medical Monitor, responsible for the medical monitoring of clinical trials, and as medical expert for Phase 1-3 studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.
· Directs the planning, preparation, writing and reviews of aggregate medical safety reports in coordination with the program’s Pharmacovigilance/Safety lead.
· Works with study and program teams to achieve program goals and provides deliverables in approved timeframes.
· Supports the development of regulatory documents for filings and agency meetings
· Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
· Participate in preparation of prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
· Remains up to date with current information on pharmaceutical regulations, guidelines, and practices, as well as therapeutic area knowledge to ensure consistent best practices across all activities including maintaining knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing
· MD degree with oncology experience preferred.
· Experience with medical monitoring in clinical trials
· Preferred 5+ years of broad experience in industry/drug development and/or clinical research with oncology (preferred) therapeutic area.
· Ability to work with a high level of autonomy/independence
· Strategic abilities and capability to take the lead and “ownership” of programs within specific indication areas
· Ability to analyze and interpret clinical safety and efficacy data and develop written reports and presentations of those data
· Strong oral & written scientific communications skills
· Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings)
· Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships and work successfully in a cross functional team
· Ability to travel up to 20%, including international travel