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Sr. Clinical Trial Manager/Associate Director, Clinical Operations San Francisco, CA/Hybrid - BridgeBio
Description
About QED Therapeutics & BridgeBio PharmaQED 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
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.The Sr. Clinical Trial Manager/Associate Director manages the operational activities of assigned clinical programs.
This individual role provides a level of expertise aligned with the principles and standard practices for operating activities of clinical trials.
Act as the lead for assigned projects and provide regional insight to global projects where applicable. Responsible for CRO oversight, training, vendor management, and review of agreements related to CRO clinical activities.Partner with internal and external stakeholders to ensure continuous harmonized operations of clinical operations activities and maintain high standards for functioning in a cross-functional environment.
Global trial experience is a plus.Responsibilities
Responsible for representing Clinical Operations (ClinOps) on cross-functional study teams and Vendor, CRO operational meetings, and ensuring compliance with global operational standards and procedures
Provides leadership for ClinOps-related issues and advises management team of potential problems and solutions
Responsible for the review and oversight oftasks in study monitoring plans foroperations and all operational activities associated with clinical trials
Responsible for ensuring that allcomponents of the trial master file (TMF/eTMF) are up-to-date and accurate for QED-assigned investigational trials
Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance
Responsible for operational guidance for investigators and providing CRO training related to the study conduct
Responsible for reviewing study budgets and master ICF templates for study start-up
Responsible for managingqueries for clinical studies from CROs and addressing issues raised by CROs or other service providers
Participate in the conduct of audits and support regulatory inspections related to GCP
Address consistency in the collection, processing, and evaluation of clinical data
Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
Contribute to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
Represent Clinical Operations on cross-functional teams
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 required in a scientific/medical field. Advanced degree preferred
Minimum eight years of experience in Clinical Operations, working with CROs and other vendors at all stages of development within the biopharma industry
At least five years of management experience in a clinical research environment
Experience in rare / orphan disease and pediatric studies preferred
Experience in maintenance of a submission ready eTMF required
Previous experience working in a cross-functional environment
History of successfully developing effective relationships with outside vendors and CROs
Outstanding verbal communication skills, which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
Demonstrated skills in negotiation, multi-tasking, organization, and decision-making
Proficiency in databases, coding, and data mining methodologies as well as Microsoft applications
Strong knowledge of GCP and working knowledge in ICH
Knowledge of GDPR and how to apply appropriate practices to clinical trials
Ability to travel to regional and global sites
Prior experience working in a start-up environment is a plus
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
Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.
Below is the anticipated salary range for candidates for this role who will work in California.The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.
BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.#J-18808-Ljbffr
