Sr. CTM/Associate Director, QED Alliance support

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.

Company Overview

QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

What You'll Do

As a Senior Clinical Trial Manager / Associate Director, Clinical Operations, you will be responsible for the operational planning, execution, and delivery of clinical trials, potentially across multiple studies. You will oversee CROs, vendors, and site operations, ensuring alignment with protocols, GCP, SOPs, and regulatory requirements while driving quality, timelines, and budget adherence. You will drive operational excellence and inspection readiness while contributing to continuous improvement across Clinical Operations.

Responsibilities

• Lead day-to-day clinical trial operational execution from start-up through close-out

• Oversee quality control by developing, implementing, and training on SOPs, as well as creating monitoring and oversight processes to ensure compliance with GCP and regulatory guidelines.

• Provide leadership on Clinical Operations issues, proactively advising management on risks, solutions, and operational strategies to ensure studies remain on track.

• Build and maintain strong relationships with investigators and site staff, ensuring clear communication on study conduct, specimen tracking, and data review.

• Provide oversight of CROs and vendors, including performance management, site management activities, training and operational guidance; conduct gap analyses, manage risks, and resolve issues proactively.

• Partner with cross-functional teams to ensure efficient trial operations, including supply chain planning and coordination for clinical and non-clinical trial materials.

• Support audit and regulatory inspections, addressing GCP compliance requirements and collaborating on continuous improvement initiatives.

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

• Hold a bachelor’s degree in a scientific or medical field required; an advanced degree is preferred.

• 8-12+ years of experience managing day-to-day clinical trial operations. Proven ability to build and manage effective relationships with CROs and vendors; experience in rare or pediatric disease trials preferred.

• Proven success leading cross-functional teams to deliver clinical trials from start-up through close-out, including financial oversight, data review, database lock, and reporting.

• Skilled at balancing detailed operational oversight with a strategic, big-picture perspective to deliver results aligned with company goals.

• Recognized for leadership, with excellent communication, organizational, and multitasking skills; proficient in tools such as Smartsheet is a plus.

• Strong vendor management expertise and experience with inspection readiness, quality assurance, SOP development, and CAPA management.

• Travel is required on a periodic basis to carry out responsibilities.

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