Associate Director, Clinical Operations

Full-TimeCalcilytixSan Francisco, CAClinical Operations

Apply Now

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 Associate Director will serve as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Calcilytix and Cantero Therapeutics Inc. (affiliates of BridgeBio Pharmaceuticals). This role should demonstrate strong matrix management skills, confidence in working independently, and have proven ability to champion a team to deliver on key study milestones. In addition, the Associate Director will be responsible for assisting in study design, planning, and execution of clinical trials while operating within budget and per established timelines, regulatory and quality standards. 
Responsibilities:
  • Study Execution: Oversee and manage the execution of one or more phase 1-3 clinical trials. Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution
  • Study Planning and Management: Establish and coordinate all ongoing study management activities, including leading the cross-functional study team development of an overall study execution plan to deliver key study deliverables. Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget
  • Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend Project Team and/or Executive Team Meetings, as required
  • Study Site Management: Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; contributes to the development of abstracts, presentations, and manuscripts for studies
  • Clinical Trial Budgeting: Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to management and finance; review vendor invoices against the scope of work and work completed to date; identify and communicate discrepancies
  • Quality Control: Support the development of quality control processes and study plans to ensure that clinical activities are compliant with Good Clinical Practice and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations
  • Supply Chain Management: Support clinical and non-clinical supplies planning for trial execution

  • 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:
  • BA/BS required; in a scientific/medical field preferred
  • At least 10+ years of experience in managing global clinical trials at all stages of development
  • Experience in rare/orphan disease areas is preferred
  • Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
  • Demonstrated successful management and oversight of CROs and other service providers
  • Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings
  • Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities
  • Organize and/or participate in specific study-related advisory committees (e.g., steering committee, data monitoring committees, adjudication committees)
  • Strong vendor management experience required
  • Experience in the management and maintenance of EDC, CTMS, IxRS, ePRO, etc.
  • Experience in Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure
  • Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities
  • Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
  • Demonstrate strong leadership and matrix management skills, ability to multi-task in a dynamic and fast-paced environment
  • Strong interpersonal, negotiation, influencing, problem-solving skills
  • Excellent written and verbal skills required
  • 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.
careers

Associate Director, Clinical Operations

Full-TimeCalcilytixSan Francisco, CAClinical Operations

Apply Now