Director of Clinical Operations - Gene Therapy

Who You Are

Reporting to the SVP of Development Operations, this individual will function as a cross-functional study team lead for the clinical development program, responsible for the delivery of 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 key study milestones. In addition, this individual will be responsible for operating within budget and in accordance with established timelines and quality standards.

Responsibilities

• Establish and coordinate all on-going study management activities, including leading the cross-functional study team to develop an overall study execution plan to deliver on key 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
• Lead team meetings, as assigned, both internally and with externally
• Attend BBGT Project Team and / or Executive Team Meetings, as required
• 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; contribute to the development of abstracts, presentations, and manuscripts for studies
• Maintain oversight of study budgets, including regular forecasting and internal reporting
• Review vendor invoices against the scope of work and work completed to date, and to identify and communicate variances
• 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
• 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
• Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
• Other duties as assigned

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 manage and deliver 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
• Preferred 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
• 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
• 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 (eg, Smartsheet)
• Position title based on experience, capabilities and demonstrated competencies

What we offer

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
• Learning and development training to help employees be the best version of themselves
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
• Excellent benefits package
• Flexible PTO
• With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
• 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
• A platform for meaningful scientific contributions to shine
• Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so