This clinical-stage biopharmaceutical company is currently seeking an Executive Medical Director. Based remotely, this individual will be responsible for driving the design & execution of an innovative adult and pediatric neurologic drug development clinical program.
- Develop and implement high quality clinical studies to support the CDP including biomarker and translational studies, natural history studies, and clinical trials
- Participate in interpretation of data analyses of clinical trial results and authoring clinical trial reports
- Provide medical input into regulatory document preparation
- Direct publication planning, advisory board meetings and training programs
- Lead clinical study teams
- Provide medical monitoring, safety assessment and overall oversight for all clinical studies supporting the CDP
- Establish and operate within appropriate timelines and budgets for clinical studies
- Develop and maintain strong relationships with program counterparts in internal functions as well as external collaborative relationships
- Present at investigator meetings, advisory meetings, regulatory meetings, and represent Praxis at professional meetings
- Contribute medical leadership and guidance to business development efforts
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. Specialty training in neurology or pediatric neurology with expertise in epilepsy, neurophysiology or pain, is highly desirable.
- At least 5 years of clinical trial experience and at least 2 years of pharmaceutical/biotechnology clinical development experience in neuroscience.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. Formal training in clinical research methods is a plus.
Please apply directly or for further information, please call or email Annabelle Clark: firstname.lastname@example.org or 646 439 0497