Strategic Operations Manager at Pontosense developing operational foundations for revenue growth and operational capacity in a hybrid work environment.
About the role
- Senior Director, Clinical Leader overseeing clinical development for late phase compounds at Johnson & Johnson. Leading cross-functional teams to innovate healthcare solutions and launch products effectively.
Responsibilities
- Responsible for the development and execution of the clinical development plan
- Leads Cross-functional Clinical Team; supervises, develops and recruits junior medical staff
- Responsible for the oversight of medical monitoring/reporting and safety activities
- Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed
- Prepares results of product research in preparation for global health authority submissions
- Assists Regulatory Affairs in the development of drug/device regulatory strategies
- May act as company spokesperson regarding publication of clinical research findings
- Helps explore and evaluate new product ideas
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
- A minimum of 3 years of Phase II/III development experience within industry
- Board Certification or Eligibility in Psychiatry or neurology preferred
- Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required
- 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
Benefits
- health insurance
- savings plan
- pension plan
- disability plan
- long term incentives
- vacation pay
- sick time
- holiday pay
- work, personal and family time off
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Strategic Operations Manager at Pontosense architecting revenue and operational engine. Improving operational capacity and revenue growth through structured planning and cross - functional initiatives.
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