Sr. Director, Drug Safety & 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.

What You'll Do

The Sr. Director, Drug Safety & Pharmacovigilance, will be responsible for managing all aspects of the drug safety functions of the  CROs and will be an integral member of the Safety Management Team. In addition, you will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Writing to determine the safety strategy.

Responsibilities

• Manage all aspects of safety and pharmacovigilance for assigned products to ensure a compliant and sound safety strategy in both clinical trials and the post-marketing setting
• Assists in the assessment of safety data and safety signals for internal Safety Management Committee DMCs, DSURs, IBs, CSRs, CSR SAE narratives, CCSIs, product labeling, RMPs, new drug applications, safety label updates, and other reports as necessary
• Support the clinical development team in the review of critical documents, including protocols and ICFs
• Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
• Assist in the medical review of severe adverse event reports; manage the preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
• Develop and prepare assessments of safety data, safety signals, and benefits/risks for internal senior management, as well as external partners or regulatory authorities
• Assist in the authoring of aggregate reports
• Manages the drug safety CROs for SAE case processing and for compliance tracking for all safety submissions across all drug safety functions of the CROs
• Works with data management in the ongoing reconciliation of clinical and safety databases
• Acts as a liaison with external collaborators to develop processes to meet regulatory reporting requirements
• Develops and prepares reports for company management as well as external regulatory agencies
• Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, and other RAs
• Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs
• Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

Where You'll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.

Who You Are

• A 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 (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least three years of oversight management experience (line management or CSO management)
• Experience in both clinical development and post-marketing safety
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
• QPPV service management and oversight, PSMF authoring experience
• FDA and EMA inspection experience for new approvals
• Growing a clinical trial drug safety system into a global post-marketing PV system
• Demonstrated ability to successfully manage a drug safety team or a drug safety CRO for a clinical program with responsibilities for expedited reporting, on-time DSUR preparation, and meeting corporate goals and key performance indicators
• Safety signal evaluation, management, and tracking, including supporting regulatory documentation
• Experience in drug safety audits and agency inspections, as case processing, DSUR, and CSO management as a subject matter expert
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines, and the demonstrated ability to manage drug safety and pharmacovigilance regulatory requirements during the conduct of 2 or more clinical trials
• Experience in working with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
• Experience with drug safety and clinical trial aspects of clinical trial design, protocol development and review, CRF and SAE Form preparation, site initiation visit safety reporting slide preparation, and training
• Experience in investigating and managing potential product quality defects
• Management of compliance deviations and formulations of CAPAs
• Post-marketing labeling experience as it pertains to safety
• Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Must be able and willing to travel periodically

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities