Sr. Director, Scientist

Who you are

You have extensive experience in overseeing clinical development and safety surveillance, with a strong understanding of product safety profiles. Your background includes managing CROs and collaborating with regulatory authorities to ensure compliance and safety in biopharma. You thrive in environments that challenge convention and push the boundaries of innovation, making you a perfect fit for a role that demands both leadership and scientific expertise.

You are adept at identifying emerging safety trends and defining safety profiles based on cumulative safety data. Your ability to facilitate Safety Management Committees demonstrates your leadership skills and your commitment to patient safety. You understand the importance of data in making informed decisions and are skilled at preparing CTD documents and engaging with regulatory authorities.

Your passion for biopharma and dedication to developing life-changing medicines for patients with unmet needs drives your work. You are excited about the prospect of working alongside some of the most respected minds in the industry, and you are ready to contribute to groundbreaking advancements in rare diseases.

Desirable

Experience in a similar role within the biopharmaceutical industry is a plus. Familiarity with regulatory processes and safety management strategies will set you apart. You are a problem solver who is not afraid to ask "why not?" and challenge the status quo.

What you'll do

In this role, you will oversee all aspects of the assigned product’s safety profile, from clinical development to post-approval safety surveillance. You will manage relationships with CROs and other partners that provide clinical and safety data, ensuring that all safety concerns are addressed promptly and effectively. Your leadership will be crucial in facilitating Safety Management Committees for designated products, where you will identify emerging safety trends and recommend necessary safety actions based on cumulative safety data.

Collaboration is key in this position. You will work closely with the regulatory and clinical development teams to establish the safety strategy for marketing authorization applications. This includes preparing CTD documents and engaging with regulatory authorities to ensure that all safety protocols are met. Your expertise will guide the team in authoring responses to regulatory inquiries, ensuring that the safety profile of the product is clearly communicated and understood.

You will play a pivotal role in defining the safety profile of products, making recommendations based on data analysis and emerging trends. Your insights will help shape the future of biopharma, as you work to develop innovative solutions for patients with rare diseases.

What we offer

At BridgeBio, we offer a competitive salary range of $262,000—$370,000 USD, reflecting your experience and expertise in the field. You will have the opportunity to work remotely from anywhere in the United States, allowing for a flexible work-life balance. Our culture encourages innovation and collaboration, and we are committed to empowering our employees to solve complex problems and achieve the impossible.

Join us in our mission to redefine the future of biopharma and make a meaningful impact on the lives of patients. We believe that together, we can achieve groundbreaking advancements in medicine and create a better future for those in need.