Executive Director, Clinical Lead
Our client is a clinical-stage biopharmaceutical company focused on innovative therapeutics for life threating diseases. They have asked us to assist them in their search for an Executive Director, Clinical Lead.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides strategic medical leadership that integrates knowledge of disease pathophysiology and clinical course with the hypothesized mechanism of action of the drug.
- Develops and implements clinical studies to support clinical development plans, including biomarker and translational studies, natural history studies, and clinical trials.
- Participates in interpretation of data analyses of clinical trial results and authoring clinical trial reports.
- Provides medical input into regulatory document preparation.
- Directs publication planning, advisory board meetings and training programs.
- Leads clinical study teams.
- Provides medical monitoring, safety assessment and overall oversight for all clinical studies.
- Establishes and operates within appropriate timelines and budgets for clinical studies.
- Develops and maintains strong relationships with program counterparts in internal functions as well as external collaborative relationships.
- Presents at investigator meetings, advisory meetings, regulatory meetings, and represents the organization at professional meetings.
- Contributes medical leadership and guidance to business development efforts.
- An MD, Doctor of Osteopathy (DO), or non-US equivalent of an MD is required.
- Must have specialty training in neurology or pediatric neurology.
- Must have at least five years of clinical trial experience and at least two years of pharmaceutical or 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 is required.
- Formal training in clinical research methods is a plus.
- Must possess excellent oral and written English communication skills.
- Requires a high level of integrity and the ability to bring out the best in others, intellectually and interpersonally, on a cross-functional team.
- The ability to prioritize across complex clinical research studies is required.
- Demonstrated strategic and critical thinking skills are required.
- The ability to interact externally and internally to support the scientific and business strategy is required.
- Must have the ability to exercise judgment and address complex problems as well as create solutions across multiple projects.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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