About ML Bio Solutions & BridgeBio Pharma
ML Bio Solutions, an affiliate of BridgeBio Pharma, is a biotechnology company founded by the McColl and Lockwood families after a family member was diagnosed with the condition. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.
To learn more about our story and company culture, visit us at https://mlbiosolutions.com/ | https://bridgebio.com
Who You Are:
The Senior Clinical Research Associate is responsible for managing operational activities of new and ongoing clinical trials for BBP-418, the investigational drug therapy being developed by ML Bio. This person will lead assigned projects and provide regional insight to global projects where applicable.
Reporting to the Associate Director/Director, Clinical Operations, this individual contributor will provide a level of expertise aligned with the principles and standard practices for the operational activities of clinical trials at ML Bio.
- Represent Clinical Operations (ClinOps) on cross-functional study teams and Vendor, CRO operational meetings and ensure compliance with global operational standards and procedures
- Provide leadership for ClinOps-related issues and advise management team of potential problems and solutions
- Review and oversee tasks in study monitoring plans for operations and all operational activities associated with clinical trials
- Ensure that all components of the trial master file (TMF/eTMF) are up to date and accurate for assigned studies
- Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance
- Ensure operational guidance for investigators and provide CRO training related to the study conduct
- Review study budgets and master ICF templates for study start-up
- Manage queries for clinical studies from CROs and addresses issues raised by CROs or other service providers
- Participate in the conduct of audits and support regulatory inspections related to GCP
- Address consistency in the collection, processing, and evaluation of clinical data
- Contribute to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
- Other duties as assigned
Education, Experience & Skills Requirements:
- BA/BS in a scientific discipline preferred
- At least five years of biopharma industry experience
- Must have experience working with CROs and other vendors in clinical operations/development
- Orphan drug and/or rare disease knowledge is preferred
- Strong verbal and written communication skills
- Previous experience working in a cross-functional environment
- History of successfully developing effective relationships with outside vendors and CROs
- Demonstrated skills in negotiation, multi-tasking, organization, and decision making
- Experience in CAPA preparation and closure
- Strong working knowledge of ICH GCP guidelines and FDA regulations as they pertain to the conduct of clinical trials
- Experience with Microsoft Office Suite required (Word, Excel, MS Project or SmartSheets, Outlook)
- Willing and able to travel to regional and global sites
What We Offer:
- Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
- An unyielding commitment to always putting patients first. Learn more about how we do this here
- A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
- A place where you own the vision – both for your program and your own career path
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
- Access to learning and development resources to help you get in the best professional shape of your life
- Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
- Flexible PTO
- Rapid career advancement for strong performers
- Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
- Partnerships with leading institutions
- Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.