(Senior) Clinical Trial Manager

About Calcilytix, Cantero & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing CLTX-305 (encaleret), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (a genetic cause of hypoparathyroidism due to gain-of-function mutations in CaSR). Encaleret is currently being evaluated in a Phase 2 clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.

Cantero Therapeutics, formerly known as Orfan Biotech, is an affiliate of BridgeBio Pharma founded in 2017 to develop new therapies for diseases of hyperoxaluria. Based on the initial discoveries of its scientific founder, Dr. Eduardo Salido, at the University of La Laguna in the Canary Islands, Orfan Biotech has quickly developed new compounds to treat primary hyperoxaluria and related conditions.

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://calcilytix.com/ |https://bridgebio.com

Who You Are:

The ideal candidate should assume leadership over the assigned study(ies) and ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs, and business guidelines.

Additionally, this individual will demonstrate strong matrix management skills, confidence in working independently, and a proven ability to champion a team to deliver on critical milestones for the studies and the program.

Responsibilities:

• Provide operational and implementation expertise to enable the timely progression of clinical development programs
• Provide support and oversight of clinical operations plans and budget
• Participate in the selection of CROs and other vendors, including the development of RFPs, budget negotiations, and oversight
• Manage project timelines and vendor performance to meet departmental and corporate goals
• Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites and service providers until execution
• Manage study budget and payment process for all service providers, including investigative sites
• Evaluate site and study performance metrics against agreed-upon budget, deliverables, and timelines
• Develop and implement an operational strategy for assigned clinical trials, including country selection, site selection, vendor selection, study timelines, and study budget
• Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central imaging)
• Review study documents for accuracy and quality
• Monitor and tracks clinical trial progress and provide status updates, as required
• Report and review study updates and identify risks and activities warranted to meet trial goals
• Develop action plans to address issues with investigators, clinical sites, vendors, project standards, and internal teams
• Prepare and lead team meetings internally and with vendors and clinical sites.
• Prepare and lead with minimal supervision in the planning of investigator meetings and making of presentations, as required
• Contribute to the development of clinical protocols and amendments, ICFs, CRFs, study manuals, and other clinical documents
• Develop trial-related training materials for Calcilytix team members, clinical site staff, and service providers (e.g., CRO)
• Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
• Review clinical data listings and summary tables; oversee the generation and resolution of queries
• Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant guidelines and regulations 
• Support departmental objectives as assigned by the head of 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:

• BS/BA or above in a scientific or health care discipline preferred, or equivalent combination of education and experience.
• At least ten years of experience in managing global clinical trials at all stages of development within the Biotech/Pharmaceutical industry is preferred.
• Knowledge of ICH GCP E6 R2 and GDPR requirements
• Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
• Deep understanding of clinical trial design, protocol development, and review
• Strong written and verbal communication skills
• Strong proficiency with Microsoft Office Word and Excel
• Experience in planning/leading/managing/tracking program and study-related meetings
• Considerable experience in working with cross-functional leadership and clinical teams
• Demonstrated successful management of CROs and other service providers
• Demonstrated success at clinical trial project management skills
• Experience in identifying risks, along with developing and implementing mitigation strategies.
• Experience in rare/orphan disease areas is preferred
• Experience with regulatory inspections and/or inspection-readiness activities
• Considerable expertise in authoring SOPs, study Plans, and CAPA preparations/closures
• Experience in the management and maintenance of EDC, CTMS, and a submission-ready eTMF.
• Experience with investigator-initiated studies desired
• Experience in hiring, managing, developing/mentoring, and evaluating personnel
• Self-motivated and able to thrive in a fast-paced, small company environment
• Willing to travel domestically and internationally up to 20% of the time

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.