The Neurology Medical Director will be based in the San Francisco bay area and will report to the Vice President of Medical Affairs. This role will interface with many internal and external stakeholders, including the medical science liaison (MSL) team, commercial personnel, R&D personnel, senior management, research institutions, and outside medical experts.

The Neurology Medical Director will be responsible for:

· Supporting the development, execution and communication of the scientific/medical affairs plan, with particular emphasis on the neurology indications

· Supporting cross-functional collaborations to integrate broad medical, scientific, and commercial input into the medical affairs strategy and development program

· Supporting the development of key scientific external relationships with opinion leaders

· Participating in, and providing clinical input for, safety and regulatory interactions

Key Activities:

· Provide clinical/scientific input during the development and execution of company sponsored phase IV clinical trials and assessment of investigator initiated study proposals

· Interpret clinical trial data

· Work to develop relationships with key opinion leaders, make scientific presentations at advisory board meetings, participation in key scientific meetings and external committee meetings as delegated by VP of Medical Affairs

· Identify new clinical research opportunities in on-label indications and assess potential areas for potential label expansion

· Support product lifecycle management for new indications as directed by VP of Medical Affairs and VP of Portfolio Strategy

· Provide comprehensive updates to senior management and other internal stakeholders

· Manage budget as appropriate and needed

Provide clinical content input to:

· Materials to be used by the Medical Affairs team with particular emphasis on those used by the medical science liaisons

· Review all educational and research grants for their medical and scientific merit and consistency with corporate therapeutic areas of interest

· Review all advertising/promotional materials and provide medical/scientific input through participation in the legal, medical review team of all materials to be used by the sales and marketing teams

· Provide medical review for medical information letters and content associated with CME events, new data, educational slides for health care professionals to ensure medical accuracy and consistency

· Assist in the review of Investigator-initiated trials concepts and protocols

· Assist in educating and training medical science liaisons on the product and related therapeutic area in all aspects

· Contribute to the development of Acthar® gel through participation in a collaborative and cross-functional team environment

· Other duties as assigned by the VP of Medical Affairs

Basic Qualifications

· Doctor of Medicine (MD), with preference given to US licensed physicians, plus accredited residency in neurology, board certified or equivalent

· Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

Preferred Qualifications

· MD, with preference given to US licensed physicians, plus accredited residency in neurology, board certified or equivalent

· Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

· Clinical research and/or medical affairs experience in the biotechnology/pharmaceutical industry (biotech, pharmaceutical or CRO companies), particularly in the areas of neurology

· Working knowledge of FDA regulations desirable

Functional/Technical Knowledge & Skills

· In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

· Familiarity with concepts of clinical research and clinical trial design, including biostatistics

· Sound scientific and clinical judgment

· Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines

· Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

· Demonstrated ability as a medical expert in a complex matrix environment

· History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

· Willingness to travel up to 30% of time

· Ability to manage multiple projects in a fast paced environment

· Candidate must be creative, flexible, team-oriented, and have an enthusiasm and energy level commensurate with a fast-paced, small company environment

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