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Vice President, Neuromuscular Clinical Development
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- The VP, Neuromuscular Clinical Development will partner with AskBio’s Safety and Pharmacovigilance teams to oversee medical monitoring and drug safety reporting, and will work closely with the Clinical Operations, Regulatory, Medical Affairs and Patient Advocacy teams on clinical study planning and resource management to execute global clinical studies.
- Provide input to CDP development, in line with the Target Product Profile (TPP), for successful global regulatory approvals and market access.
- Partner with IPT colleagues (including Clinical Operations, Medical Affairs, Commercial, Nonclinical, Drug Delivery and CMC) and other functional leaders to design, execute and report clinical trials.
- Manage the creation and maintenance of critical study documents assigned to Clinical Development (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures (IB), Informed Consent Forms (ICF), Risk-Based Medical Monitoring Plan, Clinical Study Reports (CSRs), regulatory documents) with high quality and consistency with CDP, TPP and AskBio SOPs.
- Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
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