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Job: Associate Director, Clinical Operations, BridgeBio Gene Therapy Inc., Raleigh, NC

General Information


Job title:
Associate Director, Clinical Operations
Job location:
Raleigh, NC  27607 United States
Requisition code:
Date posted:
09/10/2021
Compensation:
• Excellent compensation & benefits package (Base, Performance Bonus, Stock, RSU programs)
• Flexible PTO
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• Commitment to Diversity & Inclusion
Job category:
Research and Development
Employment type:
Full time

Job Description


BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit us at https://bridgebio.com

Who You Are:
Reporting to the Director of Clinical Operations, this individual will perform as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities 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 crucial study milestones. In addition, this individual will be responsible for operating within budget and per established timelines and quality standards.

Responsibilities:
Include but are not limited to:

Study Planning and Management
• Establish and coordinate ongoing study management activities, including leading discussions within the cross-functional study team to develop an overall study execution plan to deliver on crucial study deliverables
• Central role maintaining relationships with other internal functions
• Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status, evaluating and keeping in place a suitable resource plan, anticipating and mitigating risks within the timeline, quality, and cost paradigm
• Working to and supporting all BBGT priorities

Study Team Meetings
• Coordinate team meetings, as assigned, both internally and externally

Trial Site Management
• Cultivate and maintain strong relationships with investigators, and trial site managers
• Organize investigator meetings as needed
• Coordinate timely data review to identify trends and discrepancies

Clinical Trial Budgeting
• Contribute to study budget, including regular forecasting and internal reporting
• Review vendor invoices against the scope of work and work completed to date, and identify and communicate variances
• Participate in contract negotiations, as needed

Vendor Management
• Responsible for management of all vendors to support clinical operations contracted for the assigned study(ies)
• Oversee budgets and timelines, performance management, risk management, and issue resolution

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

Supply Chain Management
• Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution

Other duties as assigned

Job Requirements


• BA/BS required in a scientific/medical field, or equivalent work experience
• At least ten years of experience working in clinical development within the biopharma industry
• Demonstrated ability to successfully manage and support clinical trial deliverables from start-up through close-out, including all financial tracking and reporting activities
• Understanding of clinical trial design, protocol development, and review
• Significant experience with cross-functional leadership and clinical teams, including data review, database lock, and study reporting activities
• Vendor management experience is required given many accomplishments will come from external resources
• Experience in rare/orphan disease studies is preferred
• Experience in maintenance of a submission-ready eTMF required
• Experience in Quality Assurance, SOP and study plan writing, CAPA preparation, and closure
• Experience with investigator-initiated and industry-sponsored studies
• 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
• Leadership ability and further potential 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)
• Position title based on experience, capabilities, and demonstrated competencies
(Job number: 4051046)
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