What are the responsibilities and job description for the Clinical Trial Manager/Sr. Clinical Trial Manager, Clinical Operations position at BridgeBio?
About Calcilytix & BridgeBio Pharma
Calcilytix Therapeutics , an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluated in a Phase 3 clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.
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, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, 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 the 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 track 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 :
Education, Experience & Skills Requirements
What We Offer
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
140,000-$200,000 USD
Salary : $140,000 - $200,000
