The PositionThe 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. The Associate Medical Director 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.
This is a fulltime, onsite position based from Arrowhead's Corporate Headquarters in Pasadena, CA.
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 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
- Working independently and effectively 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 (eg cardiology, endocrinology)
- Research focused on lipids or obesity
California pay range
$260,000-$310,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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