Dir/Sr. Dir, Clinical Operations

Company: Hodinkee, Inc.
Location: New Haven
Posted on: August 5, 2022

Job Description:

Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company's genome-wide methylation analysis technology has the unique ability to distinguish the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis, and management, and in the future, it will be applied to other conditions beyond cancer.We are seeking a highly motivated individual to join the Adela Team as Director / Sr. Director, Clinical Operations (final title commensurate with experience). This is an exciting opportunity to be part of a growing, dynamic, and collaborative biotech company leveraging innovative technology positioned to change the diagnostic testing market. This newly created role will lead the overarching operational strategy for clinical research studies across programs. Through leadership, mentorship and team management, the role will be accountable for planning, implementation and execution of Adela sponsored clinical studies across the product portfolio. This is a remote based position working with team members across the United States and Canada.Position Responsibilities

• Develop the strategic direction for the operational execution of all Adela sponsored clinical trials
• -Provide expertise and oversight to ensure trials are conducted in accordance with the protocols, standard operating procedures, Good Clinical Practice, and department and corporate goals.
• -Resource planning, hiring, coaching, mentorship and providing direction to the clinical operations team.
• Provide operational expertise in cross-functional meetings and corporate SOPs (standard operating procedures) and initiatives.
• Accountable for the preparation of study budgets; participates in negotiation of contracts with study partners.
• Accountable for all study related activities including the recruitment and enrollment strategy, study start-up plans, study execution and close out process to ensure trials are conducted on time, within budget and in a manner to ensure all requirements are met.
• Partner with the VP, Clinical Development and Associate Director, Clinical Operations to plan and communicate with cross-functional areas to ensure proper execution, conduct of clinical trials, and generate quality clinical data.
• Accountable for the evaluation, selection, and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.
• Anticipate operational challenges, create, and implement solutions.
  
• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.
• Responsible for building collaborative and productive relationships with internal/external partners.
• Perform other duties as requested by the senior management.Required Skills
  • Requires a BA/BS preferably biology, biochemistry, or related areas (advanced degrees desirable).
  • At least 12+ years of experience in direct project management of studies within clinical research operations.
  • Demonstrated ability to lead cross-functional teams
  • Experience with regulatory submissions and inspections of clinical trials

Keywords: Hodinkee, Inc., New Haven , Dir/Sr. Dir, Clinical Operations, Healthcare , New Haven, Connecticut