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 app