Associate Director, Data Management

About Navire Pharma & BridgeBio Pharma

Navire Pharma, an affiliate of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire’s team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

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://navirepharma.com | https://bridgebio.com

Who You Are:

The Associate Director, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management personnel and activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk‐Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock. The employee must lead data review activities and engage different functional groups leading to active participation in ensuring data integrity and completeness.

Other responsibilities include a contribution to the definition of defined company data standards and conventions. Functioning as an advisor for Clinical Data Management activities to all project teams and the staff under direct supervision, this individual will support the development and implementation of departmental Standard Operating Procedures (SOPs) and work practices. May contribute to department and other project budget planning.

The employee must conduct their work activities in compliance with all relevant laws, regulations, regulatory guidelines, and all ML Bio policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.

Responsibilities:

• Provides vendor oversight to ensure quality and timeliness of deliverables, compliant with the study requirements, SOPs and GCPs
• Represents clinical data management or oversee vendor D.M. representation in meetings with relevant cross-functional teams, external vendors, and regulatory agencies
• Directs D.M. activities (could be via a vendor) through program lifecycle, including design and development of study database/EDC, user acceptance testing, query management, and database lock
• Create or oversee vendor creation of thorough data quality checks and data review strategies to ensure the integrity of the clinical data
• Oversees reconciliation between EDC and non-EDC data such as labs and, in collaboration with Pharmacovigilance, SAE reconciliation
• Contributes to the development of outsourcing strategies and relationships with external partners or CROs
• Budget assessment, training, and oversight for all D.M. services from study start-up through study close-out and final reporting
• Responsible for managing and tracking work orders associated with clinical D.M. activities to ensure the operating costs for the D.M. department are within budget
• Possesses excellent interpersonal communication skills (written and verbal)
• Strong attention to detail
• Previous CDSIC experience is desired
• Proficient in the use of clinical data management systems (e.g., Medidata Rave, Medrio, and Veeva Vault)
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:

• Bachelor’s Degree with significant relevant work experience in Clinical Research, Computer Science, Project Management, or related field
• Experience within a clinical data leadership role in the pharmaceutical/device industry or CRO (preferably within a medium/large pharma or CRO)
• Advanced knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.)
• Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization
• Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment
• Demonstrates a solution-oriented approach to problem-solving and a “can do” attitude
• Advanced knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g., ICH, GCP, safety reporting)
• Advanced knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials

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.