Overview
Senior Director, Clinical Leader - Neuropsychiatry at Johnson & Johnson Innovative Medicine. This role leads medical and scientific strategies for late phase compounds (Ph2b/3) and oversees cross-functional execution and regulatory readiness.
Position Summary
The Senior Director, Clinical Leader (CL) is responsible for development and execution of medical and scientific strategies for late phase compounds (Ph2b/3), and operational implementation, delivered through the effective leadership of a cross-functional Clinical Team (CT). The CL leads the team to develop products in a timely and cost-effective manner and is responsible for the clinical development plans (including life-cycle management, geographic expansion, and post-marketing commitments), protocol development, quality execution of clinical studies, preparation and ownership of clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are project physicians. Team leadership via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, data management, medical writing, biostatistics, global medical safety, pharmacogenomics, early clinical development, clinical pharmacology, data science, digital health, global clinical operations, health economics, epidemiology, global medical affairs and other scientific and business related disciplines. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.
Essential Functions
* 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
Education And Experience
* 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 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
Required Technical Knowledge And Skills
* 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
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Other
* Industries: Pharmaceutical Manufacturing
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