Director of ClinOps | Vial | Remote (USA)

Director of ClinOps | Vial | Remote (USA)

Remote US
Application ends: August 20, 2024
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Job Description

Who We Are

Vial is a global tech-driven CRO providing next-generation clinical trial management services. The Vial CRO powers its drug discovery arm, Battery Bio, an AI-powered hyper scalable biotech. Battery Bio harnesses Vial’s unique 90% lower cost structure to produce more affordable drug development with efficient, streamlined clinical trials.

Our mission is to reimagine the drug discovery process to empower scientists to cure all human disease. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision.

Vial is a San Francisco, California-based company founded by Simon Burns in October 2020. Since our founding, we have become a fast-growing company of 100+ employees with over $100 million in funding from esteemed investors including General Catalyst, Box Group, and Byers Capital.

Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery.

Here at Vial, we move incredibly fast and we will look to you to build a culture emphasizes our values and commitment to excellence. Working with the team, you’ll will develop and lead our workforce strategy, building out our policies and programs as the company scales. You’ll provide guidance and counsel and have the opportunity to improve and impact every employee’s experience.

Overview

We’re seeking an experienced Director of Clinical Operations with a deep commitment to leading Clinical Development and Strategy within a CRO team. As the Director of Clinical Operations, you will play a pivotal role in supporting both Business Development and Clinical Operations. You will provide crucial insights into Clinical Development and strategy during the sales process. This includes advising on trial design, identifying common pitfalls in various therapeutic areas, recommending Key Opinion Leaders (KOLs) to collaborate with, and devising effective recruitment, monitoring and operational strategies. Your expertise will be instrumental in deploying Vial’s innovative CRO model to sponsors. Reporting directly to the CEO, you will collaborate closely with both the Business Development and Clinical Operations teams.

What you’ll do

  • Clinical Operations Support
  • Responsible for the overall success of the clinical study team and the studies they support.
  • Direct line management of Clinical Project Managers and other clinical roles including performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance.
  • Point of escalation in case of challenges in project activities with Sponsor or external vendors
  • Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams.
  • Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and SOPs and conduct of respective training
  • Provide innovative and flexible operational solutions and options to the teams; assist in preparing scenarios for creative solutions to operational challenges.
  • Responsible for resource forecasting and resource allocation for clinical studies across clinical studies.
  • Strategic contribution in the process of selection and decision on participation of vendors, preferred vendors and partnership vendors.
  • Oversight on overall project/program timelines and deliverables and identification of needs.
  • Business Development Support
  • Collaborate with Business Development to offer Clinical Development/Strategy insights during the sales process, encompassing trial design, common pitfalls, KOL engagement, and recruitment strategies.
  • Prepare for general capabilities presentations and bid defenses, including comprehensive reviews of company development programs and therapeutic market intelligence.
  • Serve as a spokesperson for Vial’s CRO capabilities through webinars, events, and content marketing initiatives.
  • Contribute to generating new business opportunities for the CRO.
  • Foster and nurture relationships with potential sponsor clients in various therapeutic areas.
  • Proactively anticipate client needs and propose tailored solutions leveraging Vial’s capabilities.
  • Maintain a high level of expertise in multiple therapeutic areas by staying updated on industry news, events, and trends, engaging with Key Opinion Leaders, and cultivating strong industry relationships.
  • Facilitate the seamless transition of studies to the Clinical Operations team post-trial award, ensuring efficient cross-functional management.

What you’ll bring

  • Minimum of 9 years of experience within the CRO industry, with a focus on multiple therapeutic areas.
  • Proven track record of providing strategic insights and support to Business Development teams, with at least 5 years in Clinical Development and Strategy roles.
  • Demonstrated ability to analyze trial design, identify common pitfalls across various therapeutic areas, and develop effective recruitment strategies, with a minimum of 5 years of experience in these areas.
  • Strong network and relationships within the clinical research community, including Key Opinion Leaders and potential sponsor clients, built over at least 5 years.
  • Proficiency in utilizing technology for effective communication, virtual presentations, and document management, with a minimum of 3 years of experience.
  • Adeptness at navigating fast-paced environments and managing multiple workstreams simultaneously, especially in startup settings, with at least 3 years of experience in such environments.
  • Leadership experience, including managing teams or projects, with a minimum of 3 years in leadership roles.
  • Ability to travel (if needed) upon sponsor request