Sr. CTM/Associate Director, QED Alliance support
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- an advanced degree is preferred
- experience in rare or pediatric disease trials preferred
- proficient in tools such as Smartsheet is a plus
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.
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
- 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
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Flexible, “take-what-you-need” paid time off and company-paid holidays
- Comprehensive paid medical and parental leave to care for yourself and your family
- Professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
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What This Job Offers
Job Type
Full-time
Career Level
Senior
