Associate Medical Director / Medical Director

Responsibilities

• Support the conceptualization and design, development, execution and communication of clinical studies across a variety of therapeutic areas
• Act as a medical lead in a cross-functional team that includes medical, scientific, clinical, safety, program management and regulatory staff
• Effectively communicate protocols and other relevant information with clinical site investigators and staff
• Interpret clinical trial data and communicate results clearly and accurately
• Take hands-on responsibility for designing and managing clinical studies to evaluate the efficacy, safety, dose selection and clinical pharmacology of product candidates
• Contribute to documents, including IRB submissions, protocols, study reports, publications and regulatory submissions – including anticipated upcoming NDA/MAA submission
• Provide high-level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines
• Identify key opinion leaders and participate in clinical advisory board meetings
• Make scientific presentations at advisory boards, key scientific meetings and external committee meetings
• Identify and evaluate medical need and clinical path for new applications of RNA interference for the treatment of disease
• Support in-licensing and out-licensing activities and partner relationships

Requirements

• M.D. or MD / Ph.D. combined with research experience
• Hands-on translational research experience within a pharmaceutical or biotechnology company or in an academic setting
• Demonstrated understanding of the drug development process and a strong desire to contribute to the development of meaningful therapeutics
• Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements
• Ability to effectively evaluate outside expert advice
• Ability to clearly elucidate complex scientific and medical concepts via written and oral communication
• Independent and effective in a fast-paced, team-based environment
• Strong clinical/scientific/technical skills
• Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
• Project management skills and focus on delivery of results

Preferred

• Fellowship training (e.g. cardiology, endocrinology)
• Research focused on lipids or obesity