Director, Clinical Safety

HireTalent; Basking Ridge (NJ); Hybrid; USD 120,000 - 180,000; Full time

Job summary

An innovative firm is seeking a Director of Clinical Safety to lead product safety strategies and ensure regulatory compliance. This pivotal role involves overseeing safety leadership in clinical studies and post-marketing surveillance, collaborating across departments to manage benefit-risk throughout the drug's lifecycle. The ideal candidate will have a strong background in the pharmaceutical industry and experience in risk management. Join a forward-thinking company that values proactive safety monitoring and teamwork, and make a significant impact on patient safety and product development.

Qualifications

• 4+ years in the pharmaceutical industry or regulatory agency.
• Experience in clinical pharmacology and drug development.

Responsibilities

• Lead a team of physicians and scientists in product safety.
• Analyze data for safety signals and regulatory compliance.
• Define risk management strategies throughout the product lifecycle.

Skills

Leadership

Risk Management

Data Analysis

Regulatory Compliance

Team Management

Education

PhD in Pharmacology

MD or equivalent

Job description

Job Title: Director, Clinical Safety

Job Schedule: Prefer a local or remote-based candidate who can come into the office when needed (~ once a quarter).

Role Overview: The Director, Clinical Safety, will be a product safety lead or part of a product safety team, responsible for overall product safety strategy or specific areas of safety surveillance and risk management. This role includes providing safety leadership in clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. The individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework and will collaborate effectively across development functions and sites. This role may serve as a key member of the Global Product Team, working with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to manage benefit-risk throughout the drug's lifecycle, with responsibilities varying depending on the development stage (Phase I through commercialization).

Responsibilities:

1. Leadership and Team Management: Lead and scientifically direct a team of junior physicians and scientists responsible for product safety, including training, coaching, and reviewing team output cross-functionally.
2. Safety Representation: Represent the CSPV on the Global Product Team or specific sub-teams, providing safety leadership and serving as the primary contact.
3. Data Review and Signal Detection: Analyze data from clinical trials, post-marketing sources, and other relevant data for safety signals. Review serious adverse event reports for completeness, accuracy, expectedness, and relatedness.
4. Regulatory Interactions: Lead interactions with regulatory agencies and external experts to ensure quality outcomes in risk evaluation and management.
5. Risk Management Strategies: Define and implement strategies for identifying and managing risks throughout the product lifecycle.
6. Documentation and Regulatory Compliance: Coordinate resources to develop safety evaluation documents and participate in safety-related regulatory meetings.

Experience: 4 or more years in the pharmaceutical industry, regulatory agency, or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.