Senior Director, Drug Safety and Pharmacovigilance

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

Calcilytix Therapeutics, an affiliate within BridgeBio Pharma, is developing encaleret, a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluated in a Phase 3 clinical study and has received Orphan Drug Designation from the US FDA, EMA, and PMDA as well as Fast Track Designation from the US FDA. Results from the Phase 2b clinical study of encaleret in patients in ADH1 were published in the New England Journal of Medicine.

What You'll Do

• Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data 
• Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data  
• In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries 

Responsibilities

• Support the clinical development team in the review of key documents, including protocol and ICFs 
• Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators  
• Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary 
• Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities 
• Assist in the authoring of aggregate reports  

Where You'll Work

This a U.S-based remote role that will generally require three visits per year, or as needed visits to our San Francisco Office. 

Who You Are

• Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred 
• Requires at least ten years of drug safety and pharmacovigilance experience with at least 5 years experience in Clinical Development Safety 
• Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates
• Experience in both clinical development and post-marketing safety 
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews is highly preferred 
• Experience in drug safety audits and agency inspections 
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines 
• Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA 
• Experience in managing all clinical safety aspects of product quality defect investigations and assessments 
• Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office