Medical Director/Sr. Medical Director (CNS)

The Position

The Senior Medical Director will be instrumental in bringing important new therapies based on RNA interference to patients. The Senior Medical Director will work collaboratively with Arrowhead’s scientific and clinical teams to take drugs from discovery to early clinical research. S/he will take hands on responsibility for designing and managing translational studies and early clinical trials to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of product candidates in the CNS/Neurology therapeutic area. 

As the person in this role will interact extensively with early stage researchers in the CNS field, it is imperative that the Senior Medical Director have a background that includes significant research involvement.  Ideally, this hire will have spent time “on the bench” at some point in their career.

Responsibilities

• Provide primary medical insight and guidance for the design, development, and execution of discovery and translational in CNS
• Be responsible for medical leadership for multiple CNS clinical studies, including study start up, investigator interaction, medical monitoring and safety assessments for such studies
• Work both strategically and collaboratively management, scientific, clinical, safety, program and regulatory staff
• Author documents, including IRB submissions, protocols, CSRs, publications and regulatory submissions
• Effectively communicate scientific rationale, data, protocols and other relevant information
• Identify and evaluate medical need and clinical path for new applications of RNA interference for the treatment of CNS/neurological disease to broaden Arrowhead’s CNS pipeline
• Collaborate with scientific staff to advance new drug candidates through preclinical development
• Identify and recruit key opinion leaders; organize and participate in clinical advisory board meeting
• Make scientific presentations at advisory boards, key scientific meetings and external committee meetings
• Interpret clinical trial data and communicate results clearly and accurately
• Become an expert in current state of the art and new developments in RNA interference in industry and academia with a focus on the CNS therapeutic area;
• Support in-licensing and out-licensing activities and partner relationships
• Contribute as a key member of Arrowhead’s medical staff to the company’s non-CNS programs, as appropriate

Requirements:

• M.D./Ph.D. or an M.D. combined with research experience. Fellowship training is a plus.
• Senior Director: 15 years’ experience driving research and early clinical development, with a minimum of 8 years’ experience biotech/pharma industry in CNS/neurological indications, with progression into more senior roles
• Director:  10 years’ experience driving research and early clinical development, experience in biotech/pharma industry in CNS/neurological indications preferred
• The ideal candidate will have hands-on early/translational research experience within a pharmaceutical or biotechnology company with a demonstrated track record of moving programs forward
• 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
• Ability to work independently and as part of a team
• Interest in working effectively in a fast-paced, team-based environment