Arrowhead Pharmaceuticals, Inc. Pasadena , CA 91101
Posted 2 weeks ago
The Position
The Associate Medical Director/Medical Director will report to the head of cardiometabolic clinical development and will be instrumental in bringing important new therapies based on RNA interference to patients. This individual will work collaboratively with Arrowhead's scientific and clinical teams to take drugs from late clinical research to NDA filings and will initially focus on siRNA programs targeting cardiac and metabolic (lipids and obesity) indications. Experience in these areas is encouraged but not required. S/he will take hands on responsibility for designing and managing clinical studies to evaluate the efficacy, safety, dose selection and clinical pharmacology of product candidates. Candidates with the requisite experience may be considered for a Medical Director title.
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
Provide ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
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
Monitor and understand new developments in RNA interference in industry and academia
Support in-licensing and out-licensing activities and partner relationships
Requirements:
M.D., or Ph.D./M.D. combined with research experience
A strong desire to contribute to the development of meaningful therapeutics
Ability to effectively evaluate outside expert advice
Ability to clearly elucidate complex scientific and medical concepts via written and oral communication
Ability to work independently and effectively in a fast-paced, team-based, cross-functional environment
Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
Excellent scientific communication skills (both verbal and technical) and interpersonal skills
Possesses sense of urgency without overlooking key details; identifies challenges and problems and takes the initiative to identify solutions
Results focused
Willingness to relocate if necessary to either Pasadena or San Diego, CA
Preferred:
Hands-on clinical research experience within a pharmaceutical or biotechnology company or in an academic setting
Fellowship training in relevant specialty (eg cardiology, endocrinology)
Arrowhead Pharmaceuticals, Inc.