Associate Director, Clinical Operations at BridgeBio Full Time

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

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, Raleigh, and 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://www.qedtx.com/ | https://bridgebio.com

Who You Are

Reporting to the Sr. Director, Clinical Operations, this individual will function as a cross-functional study team lead for the clinical trial program, responsible for delivery of all clinical trial operational activities, potentially across multiple studies. 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, this individual will be responsible for operating within budget and in accordance with established timelines and quality standards.

Responsibilities

• Study Planning and Management. Coordinate and actively participate in the development and updating of study-related documents (investigator brochure, clinical protocols, informed consent forms, case report forms, clinical study reports, amendments, adverse event reporting, site training manuals) and analysis plans (including data collection and management); Monitor study progress and maintain timeline from initiation through publication of study results; work very closely with the clinical lead to advance the studies
• Quality control. Responsible for development, training, implementation and compliance of Standard Operating Procedures; Develop quality control processes and monitoring plans to ensure that all clinical activities are compliant with Good Clinical Practices and regulatory guidelines
• Clinical Trial Budgeting. Work with finance department on the development and negotiation of trial site budget and clinical trial agreements; Forecast and manage clinical trial budgets and FTE costs; Ensure accurate accruing of study costs; Review vendor invoices against contract and work completed; Oversee reconciliation of site payments against patient visits to ensure accurate payments; Identify and communicate variances
• Trial Site Management. Cultivate and maintain strong relationships with investigators, and trial site administrators; Organize investigator meetings as needed; Lead effective communications with trial sites for specimen tracking, study conduct and timely data review to identify trends and discrepancies; Contributes to development of abstracts, presentations and manuscripts for studies
• Vendor Management. Responsible for collection and preparation of all information needed to facilitate selection, on-boarding and management of CRO and vendors for outsourced activities; develop statements of work, budgets and timelines; Responsible for gap analysis, performance management, risk management and issue resolution
• Supply Chain Management. Coordinate and plan for availability of clinical and non-clinical supplies required 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 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

• BA/BS required in a scientific / medical field, or equivalent work experience
• At least 10 years of experience in managing global clinical trials at all stages of development within the biopharma industry
• Demonstrated ability to successfully lead and manage clinical trials from start-up through close-out, including all financial tracking and reporting activities
• Deep understanding of clinical trial design, protocol development and review
• Significant experience with cross-functional leadership and clinical teams, including leading data review, database lock and study reporting activities
• Strong vendor management experience required given many accomplishments will come from external resources
• Experience in rare / orphan disease studies preferred
• Experience in maintenance of a submission ready eTMF required
• Experience in Quality Assurance, SOP and study plan writing, CAPA preparation and closure
• Strong team management skills, ability to lead, train and mentor team members at all levels; experience building teams highly desired
• Experience with Inspection readiness for various Health Authority inspections, including FDA and EMA highly desired
• Ability to wear multiple hats including focusing on detailed day-to-day tasks without losing sight of the big picture
• Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
• Knowledge of GDPR and how to apply appropriate practices to clinical trials
• Strong leadership ability and character to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environment
• Excellent interpersonal, written and verbal skills required
• Working experience / knowledge of timeline management tools (e.g., Smartsheet)
• Willing to travel domestically and internationally

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