Job Purpose

This position of Associate Director/ Director-Clinical Development – Neurology, reports to the ED of Clinical Development Neurology, with medical/clinical responsibilities for our product(s) in the neurology arena.

Duties and Responsibilities 

The duties and responsibilities include but are not limited to the following: 

• The primary responsibility of this role will be to provide clinical/medical support to our neurology program(s).
• Using neurology background, works to educate and train internal and external stakeholders on the therapeutic area.
• Demonstrated ability to exercise good medical-clinical judgement in a fast paced and collaborative environment
• Work collaboratively with cross functional partners (e.g. Clin Ops, Biometrics, Pharmacovigilance, Regulatory, DMPK, Project Management, Medical Affairs, Commercial)
• Work to develop relationships with External Experts, Investigators, and Clinical Sites.
• Authors and/or collaborates in the development and review of clinical and regulatory documents (e.g. protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), etc.)
• Interact with regulatory agencies throughout the development process.
• Ability to interpret, summarize and communicate clinical data internal and external audiences
• Maintain a high degree of understanding and awareness on new and emerging developments both in the therapeutic area and in clinical development across the industry
• If an MD candidate:
  • Serve as Medical Monitor on clinical trials, and as medical expert for clinical studies to ensure study-related safety of subjects in clinical trials
  • Experience in the practice of medicine and medical monitoring experience a plus 

Qualifications

• PhD, PharmD, Medical Doctor (MD or equivalent) or other advanced degree. Physicians will be given preference
• Subject area expert and 5+ years of clinical trial experience or Clinical Development experience in a pharmaceutical or biotechnology setting
• Ability to communicate with sites and investigators on matters of clinical trial conduct
• Excellent oral and written communication skills. Confident using online communications and teleconferencing.
• Ability to communicate with teams across multiple time zones, flexibility in working hours.
• Comfortable with presenting detailed scientific data to groups, large and small, internally and externally.
• Demonstrable skills with teaching and educating both professional and lay people.
• Ability to work on several projects simultaneously.
• A thorough understanding of medical monitoring, pharmaceutical safety, reporting and surveillance processes
• A detail oriented professional who is creative and solution-orientated
• Ability to forge and develop relationships with both internal and external stakeholders
• Demonstrates strong ability to identify, diagnose and correct issues promptly
• Willingness to challenge the ‘status quo’
• A self-motivated individual who is culturally sensitive and emotionally intelligent
• Ability to fit seamlessly within a dynamic team and fast-paced environment
• Autonomous, proactive, collaborative and collegiate 

Physical Requirements

The incumbent may be required to sit, stand and walk for extended periods of time.  The incumbent may be required to climb, bend, lift, carry and kneel.  Because of the volume of work performed by computer and telephone, the incumbent will spend a considerable amount of time looking at the computer monitors and using his/her hands to operate office equipment. 

Working Conditions

This position may be based at company offices in either Durham, NC or South San Francisco. Remote working situations may also be considered. Travel of up to 20% of time is expected.