Senior Clinical Trial Manager

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Calcilytix Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing disorders of calcium homeostasis at the source. Our product candidate is an orally-administered small molecule that specifically inhibits the calcium-sensing receptor, hypothesized to restore normal serum calcium and lower urine calcium.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit us at https://bridgebio.com

Location

San Francisco, CA

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, operating procedures, quality standards, SOPs, and business guidelines. Additionally, this individual should demonstrate strong matrix management skills, confidence in working independently, and have 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
  • Identify, hire, onboard, and oversee CROs and other service providers, including evaluation of performance against metrics, timely escalation of risks and issues, and resolution of issues
  • Evaluate site and study performance metrics against agreed-upon budget, deliverables, and timelines
  • Report and review study updates and identify risk 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, vendors, and clinical sites.
  • Contribute to the development of clinical protocols and amendments, ICFs, CRFs, study manuals, and other clinical documents
  • Review study documents for accuracy and quality
  • 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, and regulations 

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
  • Knowledge of ICH GCP E6 R2 and GDPR regulations
  • 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
  • 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 rare/orphan disease areas is preferred
  • Experience with regulatory inspections and/or inspection-readiness activities
  • Considerable experience in authoring SOPs, study Plans, and CAPA preparations/closures
  • Experience in the management and maintenance of a submission-ready eTMF required
  • Experience in hiring, managing, developing/mentoring, and evaluating personnel

What We Offer

  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
careers

Senior Clinical Trial Manager

Apply Now