Sr. Director, Clinical Data Management

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 Sr. Director, Clinical Data Management is responsible for executing Data Management planning and operational activities for the <insert> development program. This includes supporting the design, development, validation, implementation, maintenance and close-out of clinical study databases, oversight of data management vendors. The Sr. Director, Clinical Data Management will lead a DM team directing and participating in hands-on data management activities in collaboration with Clinical Operations, Clinical Research, Biostatistics, and Quality & Compliance, as well as CROs or related Data Management-related service providers. The Sr. Director, Clinical Data Management will be accountable for a high level of quality for deliverables from within Data Management and from Data Management service providers and will lead DM activities in preparation for and execution of NDA/MAA submissions.

Responsibilities

• Directs the overall data management supporting assigned projects/programs for clinical research studies within the scope of project timelines, with a clear focus and emphasis on the current or projected Phase 3/4 program
• Directs the creation, acceptance and/or maintenance of EDC systems created by outside vendors for collection of clinical data
• Directs the creation/standardization of case report forms for all clinical trials
• Collaborates closely with clinical project/study teams in developing and/or defining data structure, ongoing data quality standards and clinical data acceptance rules for assigned clinical studies
• Is responsible for ensuring the data collected meet the requirements of the study objective and quality standards in collaboration with Biostatistics
• Works with consultant and internal statisticians, data managers and/or vendors that provide statistical input for clinical studies and publications to align data management and statistical requirements
• Assists in the development and implementation of internal database standards (including EDC and CDISC), external data transfer and acceptance specifications, and documentation processes for clinical data
• Compiles all clinical data in appropriate submission format for regulatory submissions in all geographies
• Develop and update SOP's associated with the data collection/handling /review processes to meet regulatory compliance and operational needs
• Ensure regulatory compliance of vendors and investigational sites with appropriate SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines
• Participates in vendor selection and contract negotiation process, including RFPs and bid defense meetings, as applicable
• Participates in the development and maintains a working knowledge of study protocols and related amendments
• Cross-functional work with biostatistics and statistical programming
• Represents Data Management in cross-functional meetings and facilitates cross‑functional activities
• Coordinates and/or provides training on data management systems, reporting tools, etc
• Authors, reviews and/or approves various study related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensures documents are maintained throughout the duration of the study
• Directs, oversees, and/or performs ongoing data review activities, including identification, tracking and resolution of data issues
• Directs, evaluates, and defines review tools and reports necessary for successful data review
• Provides oversight of external data providers and corresponding data reconciliation (e.g., IRT, safety, central and specialty labs, central labs, patient reported outcomes, etc.)
• Ensures data management timelines and deliverables, including metric output, are detailed and communicated to the study team on a regular basis

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 toward 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 or equivalent required; advanced academic degree or training preferred
• Minimum 15 years of Data Management in the pharmaceutical and or biotech industry with 5-7 years' experience in a managerial role (projects/personnel), and vendor oversight
• Knowledge and understanding of the principles, concepts, methods and standards of Clinical Data Management (CDM)
• Ability to direct and manage the activities of outside Data Management vendors
• Experience representing data management in cross-functional NDA team, and ability to oversee internal and external data management personnel
• Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
• Excellent time management, ability to coordinate workload and meet established deadlines.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Ability to review data transferred electronically, identify issues that may exist, and anticipate future needs/risks and plan accordingly Ability to motivate a team to work effectively under a changing environment
• Ability manage effectively, prioritize and solve problems

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