Responsible for the development and execution of the clinical development plan
Leads Cross-functional Clinical Team; supervises, develops and recruits junior medical staff
Molecule responsible physician
Responsible for the oversite of medical monitoring/reporting and safety activities
Evaluates adverse events (pre and post-marketing) for relationship to treatment
Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed
Interprets, reports and prepares results of product research in preparation for global health authority submissions and external communication
Responsible for assessment of medical publications emerging from the Team and its affiliates
Assists Regulatory Affairs in the development of drug/device regulatory strategies
Acts as medical contact at company for global health authorities concerning clinical/medical issues
May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees
Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities
Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
Supports early clinical development involving product potential and development for registration
Manages the budget for all project related clinical activities

MD (or equivalent) in relevant area with appropriate post-doctoral training and certification
A minimum of 5 years clinical research or pharmaceutical industry experience
A minimum of 3 years of Phase II/III development experience within industry
Board Certification or Eligibility in Psychiatry or neurology preferred
A minimum of 3 years of highly successful managerial/supervisory or related experience
Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards
Global registration experience strongly preferred
Experience working in a Matrix environment is required
Ability to interface effectively with clinical operations, medical affairs and marketing is essential
Fluent in written and spoken English
Working knowledge of the use of Microsoft suite of software products including Excel and Word
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings

medical
dental
vision
life insurance
short
and long-term disability
business accident insurance
group legal insurance
retirement plan (pension)
savings plan (401(k))
long-term incentive program
vacation – 120 hours per calendar year
sick time
40 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours

Senior Director, Clinical Lead – Neuropsychiatry

Key skills