Associate Director/Director, Clinical Operations

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. 

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.

What You'll Do

The AD/Director, Clinical Operations is responsible for oversight and management of clinical program(s) and functional activities as assigned. This position will require you to function as a cross-functional study team lead in a fast-paced environment for the clinical development program. This role should demonstrate strong matrix management skills, confidence in working independently and have proven ability to champion a team to deliver on key study milestones.

Responsibilities

• Represent Clinical Operations at the Clinical Development Team, cross-functionally and/or Global Program Team

• Study Planning and Management;

  Establish and coordinate all on-going study management activities, including leading the cross-functional study team to develop an overall study execution plan to deliver on key study deliverables

• Partners closely and effectively with other functions and functional heads to drive program forward

• Demonstrates ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking, metrics and reporting activities

• Assists and management of CRO/vendor(s) Scopes of Work (SOW), scope changes, budgets, and vendor payments; creating and tracking on all clinical study budgets

• Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors

• Contributes to building the organization

Where You'll Work

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

Who You Are

• BA/BS required in a scientific / medical field, or equivalent work experience

• At least 10+ years of experience in managing global clinical trials at all stages of development within the biopharma industry

• Significant experience with cross-functional leadership and clinical teams, including leading data review, database lock and study reporting activities

• Significant experience with BLA prep; FDA submissions and FDA audit prep and readiness

• Experience in Quality Assurance, SOP and study plan writing, CAPA preparation and closure

• Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations

• Strong leadership ability and character to build relationships in a matrix environment