Director, Clinical Safety

The Fountain Group; Virginia; Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Safety to lead safety strategy for a prominent pharmaceutical client. This remote position involves overseeing safety monitoring and risk management throughout the drug lifecycle. The ideal candidate will possess strong leadership and communication skills, ensuring effective collaboration across various development functions. This role offers the opportunity to make a significant impact on clinical studies and regulatory submissions, contributing to the safety and efficacy of innovative therapies. If you are passionate about clinical safety and looking to advance your career in a dynamic environment, this opportunity is perfect for you.

Qualifications

• Proven leadership in clinical safety and risk management.
• Strong collaboration across development functions.

Responsibilities

• Lead product safety strategy and safety surveillance.
• Collaborate with cross-functional teams for effective risk management.

Skills

Leadership Skills

Communication Skills

Risk Management

Safety Surveillance

Job description

The Fountain Group are a national staffing firm and are currently seeking a Director, Clinical Safety for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows:

Job Description:

1. Pay: 97.00-107.00/hr.
2. Length of Assignment: 1 year to start with potential to extend or convert.
3. 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 includes providing safety leadership in clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions.
4. Safety Monitoring: This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.
5. Collaboration: Strong leadership and communication skills will be utilized to ensure effective collaboration across development functions and sites.
6. Team Role: The individual may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug.
7. Responsibilities: Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).