Clinical Trial Manager

About CoA & BridgeBio Pharma

CoA Therapeutics, an affiliate of BridgeBio Pharma, is developing BBP-671, a small molecule allosteric modulator of an enzyme family known as the pantothenate kinases that control coenzyme A synthesis. This therapeutic approach may have utility in diseases associated with coenzyme A depletion, including a rare neurological condition PKAN and inborn errors of metabolism such as organic acidemias.

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://coatherapeutics.com | https://bridgebio.com

Who You Are:

The Clinical Trial Manager will lead and manage the clinical study team for assigned clinical studies, ensuring adherence to timelines and budgets, GCP/ICH requirements, and CoA SOPs. The Clinical Trial Manager will collaborate with multidisciplinary, cross-functional stakeholders to oversee the quality and integrity of clinical trial activities and deliverables, facilitate the collection of high-quality data and lead the clinical study team to drive effective decision making in a highly dynamic and complex environment.

Reporting to the Senior Director, Clinical Operations, the Clinical Trial Manager is expected to operate independently with guidance and oversight provided by the clinical program Director when needed. This position contributes to and supports the CoA research and development efforts to create meaningful therapeutics to address unmet medical needs.

Responsibilities:

• You will manage all aspects of clinical trial conduct, leading one or more studies from concept to protocol and achieving corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
• Manage CROs and third-party vendors, including setting expectations, training, managing timelines, and deliverables, and issue management
• Further manages CRO interactions, including sponsor oversight of operational, functional activities (e.g., study management, monitoring, site management, project master files)
• Manages clinical monitoring activities and the overall site management, ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• In collaboration with the clinical study team, identify study risks and develop risk mitigation plans, including communication with senior management when necessary
• Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)
• Coordinate study supplies, ensuring GCP compliance before shipment and assisting with tracking distribution and maintenance of clinical supplies for sites and study team
• Assist in the identification, evaluation, contract negotiation, and hiring of appropriate CROs and other third-party study vendors
• Organizes and participates in investigator meetings, supporting the preparation and development of meeting materials related to reports, training, and presentations as needed
• Participates in the set-up and ongoing maintenance of the Trial Master File (TMF) and oversees quality review to ensure it is complete, accurate, and up to date throughout the life cycle of the clinical study
• Support the ongoing study data reviews and data cleaning activities
• Assist and support data query process; Provide regular enrollment and program updates to senior management
• Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations
No matter your role at BridgeBio, successful team members are:


• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive towards practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements:

• Bachelor’s degree in a scientific discipline, biotechnology, or a related degree; an advanced degree preferred
• Required minimum of 5 years of clinical operations experience at a biotechnology/pharmaceutical company or contract research organization (CRO)
• Required minimum of one year of clinical study management experience
• Pediatric, orphan drug, and/or rare disease knowledge is preferred
• Strong verbal and written communication skills
• Ability to build and maintain strong working relationships within the department, cross-functionally, and with external vendors to meet project and business timelines and goals
• Must be able and willing to travel on occasion

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
#Li-Hybrid

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.