Senior Director, Clinical Leader – Neuropsychiatry
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • California, Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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 oversight 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.
Benefits
- Health insurance
- Professional Development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical development planclinical trials designmedical monitoringadverse event evaluationregulatory strategiesclinical researchPhase II developmentPhase III developmentclinical drug developmentbudget management
Soft skills
leadershipteam supervisioncommunicationinterpersonal skillsmanagerial experiencecross-functional collaborationstrategic thinkingproblem-solvingpresentation skillsevaluation skills
Certifications
MDBoard Certification in PsychiatryBoard Certification in Neurology