Senior Clinical Trial Manager

Full-TimeNavireSan Francisco, CAClinical Operations

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Navire Pharma, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire’s team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

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://navirepharma.com / https://bridgebio.com

Who You Are:

The Senior Clinical Trial Manager (Sr. CTM) is responsible for managing operational activities of assigned clinical programs. This individual role provides a level of expertise, aligned with the principles and standard practices for operational activities of clinical trials Navire. This individual will act as the lead for assigned projects and provide regional insight to global projects where applicable, be responsible for CRO oversight, training, vendor management, and review of agreements related to CRO clinical activities. The Senior CTM will partner with key stakeholders - internal and external - to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for functioning in a cross-functional environment.  Global trial experience a plus. This position will report to the Director of Clinical Operations.
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
  • Provide leadership for ClinOps related issues and advise management team of potential issues and solutions
  • Responsible for the review and oversight of tasks in study monitoring plans for operations and all operational activities associated with clinical trials
  • Responsible for ensuring that all components of the trial master file (TMF/eTMF) are up to date and accurate for Navire assigned investigational trials
  • Monitor global regulatory intelligence for global industry practices for operational efficiency and compliance
  • Responsible for operational guidance for investigators and provide CRO training related to the study conduct
  • Responsible for reviewing study budgets and master ICF templates for study start-up
  • Responsible for managing queries for clinical studies from CROs and address 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
  • 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
  • Support Navire sponsored clinical trials and development programs
Education, Experience & Skills Requirements:
  • Bachelor’s degree in a scientific/medical field is required; an advanced degree preferred
  • Minimum of 8 years of experience in Clinical Operations, working with CROs and other vendors
  • At least 5 years of management experience in a clinical research environment
  • 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 we well as Microsoft applications
  • 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 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
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Senior Clinical Trial Manager

Full-TimeNavireSan Francisco, CAClinical Operations

Apply Now