Senior Director, Clinical Lead – Neuropsychiatry

Role Overview

• Responsible for the development and execution of the clinical development plan and has ownership for the design of clinical trials and for the content of clinical study reports
• 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 and determining requirements for any corrective actions or health authority reporting
• 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

Requirements

• MD (or equivalent) in relevant area with appropriate post-doctoral training and certification
• A minimum of 5 years clinical research or pharmaceutical industry experience is required, inclusive of a minimum of 3 years of Phase II/III development experience within industry.
• An MD (or international equivalent) is required.
• 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 is required.
• Global registration experience strongly preferred, as is experience working or interacting with Health Authorities.
• 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.

Benefits

• medical
• dental
• vision
• life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• consolidated 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