R&D MD VP

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. At BridgeBio, we value curiosity and experimentation—including the ethical thoughtful use of AI to improve clarity, speed, and quality of work.

Who You Are

The VP of Drug Safety will be responsible for managing all aspects of the drug safety functions of the CROs and will be an integral part of the Safety Management Team. In addition, they will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, Medical Information/Liaisons, and Medical Writing for investigational compounds across the company. Responsibilities can grow to include marketed product safety and pharmacovigilance when appropriate.

Responsibilities

Contribute to and lead a full range of pharmacovigilance (PV) activities for investigational products, including operational activities, cross-functional activities with other departments, quality systems, audits, and inspections

Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested

Manage oversight of external activities by vendors (CROs), including case processing, expedited safety reporting, and partner data exchange. The successful candidate will be responsible for oversight of safety operations strategy, including case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, and training

Lead Safety section of submission documents

Participate and/or lead presentations with Regulatory Authorities

Participate and/or lead meetings with consultants and investigators

Participate and/or lead advisory panel meetings

Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable

Develop proactive risk management strategies for investigational compounds

Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance/risk management activities

Contribute to and review investigator’s brochures, safety sections of clinical study protocols, single and aggregate expedited reports, areas of regulatory submissions, or regulatory responses (including IRBs or Ethics Committees)

Plan, manage/perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:

Continuous monitoring and further development of the product safety profile

Safety issue management

Set-up of safety analyses in both clinical trial and post-marketing databases

Provide company causality assessments

Provide clinical input in signal detection and perform signal evaluation activities

Provide a clinical (drug safety) perspective at Safety Management Committee meetings

Participate in Bridgebio Safety Board when requested

Maintain currency with applicable PV global regulations and industry guidelines

Oversee preparation, development, implementation, and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements

Contribute to inspection readiness activities

Develop strategies to further enhance and optimize the impact of the Drug Safety and PV department

Education, Experience Skills Requirements

Post-graduate degree (MD, DO) or international equivalent from an accredited institution

Excellent communication and interpersonal skills

Minimum of 12 years of relevant industry experience, which includes at least 9 years of senior drug safety experience

Must have experience in both clinical development and post-marketing drug safety

Must have Regulatory Submission experience

Minimum of One (1) to three (3) years of project leadership/management experience

Experience writing safety sections of marketing applications, integrated safety summary, DSUR/PSUR preferred

Excellent and broad understanding of the pharmaceutical industry and the future trends and developments in pharmacovigilance

Management Experience preferred

Must have safety experience in mu…