Reference Number: JO-2001-444884
Medical Director, Clinical Development, Derm
Job Type: Permanent
Location: United States
In collaboration with the program Clinical Development Lead and 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 input into the design and conduct of clinical trials, assessment and interpretation of safety data and contribute to investigator training.
Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management.
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 and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
Serve as Medical Monitor, responsible for the safety 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 programs Pharmacovigilance/Safety lead.
MD or DO preferred or equivalent training (i.e., PharmD with clinical residency or DNP) and/or experience in the life sciences required. Dual degree; MD/PhD or PharmD/PhD strongly preferred
Preferred 8+ years of broad bio/pharmaceutical industry experience in drug development with therapeutic area experience in dermatology