Sr. Director, Clinical Data Management

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “Moneyball for biotech” approach, pooling projects and promising early-stage research from academia under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare diseases and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

Calcilytix Therapeutics, an affiliate within BridgeBio Pharma, is developing encaleret, 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 Designation from the US FDA, EMA, and PMDA as well as Fast Track Designation from the US FDA. Results from the Phase 2b clinical study of encaleret in patients in ADH1 were published in the New England Journal of Medicine.

What You'll Do

The Sr. Director, Clinical Data Management is responsible for executing Data Management planning and operational activities for the Calcilytix 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

Who You Are

• 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

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities