Venthera is a young and dynamic company within the BridgeBio family. Our lead program is focused on the topical delivery of a PI3K inhibitor for the treatment of venous and lymphatic malformations involving the skin. Our “right drug, right tissue” approach is built on a foundation of developing drugs to suppress causative pathways inappropriately activated by a driver mutation underlying the disease. We integrate quantitative assessment to ensure delivery of an optimal amount of the drug to affected sites.
Who You Are
Venthera is looking for a talented and highly motivated operations leader to drive the strategy, coordination, and implementation of a first-in-human clinical study, enrolling a rare-disease population. The protocol will engage multiple sites in defining an initial safe and well-tolerated dose and, subsequently, in a longitudinal, placebo-controlled period to explore efficacy. The role will be responsible for properly resourcing, managing and executing (the first-in-human and subsequent) clinical studies within budget and in accordance with established timelines and quality standards.
- 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, and site training manuals) and analysis plans (including data collection and management). Monitor study progress and maintain timeline from initiation through the publication of study results; work very closely with the clinical lead to advance studies.
- Patient Recruitment and Retention. Build and execute strategies for patient enrollment to include sourcing, selecting, contracting, and oversight of specific vendors related to patient recruitment and retention. Partner with key-opinion leaders and patient advocacy organizations to develop collaborations related to increasing clinical trial awareness.
- Quality control. Develop and implement Standard Operating Procedures, including the training of colleagues. Develop quality-control processes and monitoring plans to ensure that all clinical activities are compliant with Standard Operating Procedures, Good Clinical Practices, and regulatory guidelines.
- Clinical Trial Budgeting. Work with the 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 accrual of study expenses. Review vendor invoices against contract and work completed, and oversee reconciliation of site payments against patient visits – ensure accuracy of payments. Identify and communicate variances to appropriate management and finance personnel.
- 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 study conduct (including tracking of specimens) and timely data review to identify trends and discrepancies. Contributes to the development of clinical abstracts, presentations, and manuscripts.
- Vendor Management. Collect and prepare all information needed to facilitate selection, contract negotiation, 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
- Other duties as assigned.
Education, Experience & Skills Requirements
- BA required in a scientific/medical field. Advanced degree preferred.
- 10+ years progressive experience in clinical operations at a study sponsor preferred
- Demonstrated ability to successfully develop, implement, manage and complete Phase 1 and 2 clinical trials (involving multiple sites) on time and on budget – solid working knowledge of study initiation, execution, data analysis and site closing procedures
- Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices and ICH regulations and guidelines and the application to the conduct of clinical trials
- Experience with US regulatory interactions (related to clinical trial conduct)
- Experience in study conduct and initiation in the EU (and/or other ex-US regions)
- Ability to coordinate cross-functionally to procure and plan for clinical trial drug supplies
- Willingness to go beyond normal “clin ops” role to be a company leader, driving timelines, integrating all the pieces of the trial, etc.
- Experience in a fully outsourced model.
- Ability to work in a small company with a largely virtual environment; startup experience preferred
- Ability to manage complexity and uncertainty
- Strong team interaction and communication skills
- Organized, detail-oriented, and self-starting
- Embraces company core values: 1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts, and 5. let the science speak
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