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Director, Clinical Research Programs

4 months ago

Scottsdale, United States CND Life Sciences Full time
Job DescriptionJob Description

Reporting, to CND's Chief Scientific Officer and collaborating closely with the Chief Medical Officer, the Director of Clinical Research Programs) is responsible for overseeing three key program areas of CND's clinical development activities:

  • NIH and other grant-funded, multicenter clinical studies
  • Company-sponsored health economic and outcomes research (HEOR) studies
  • Patient registry collaborations

The Director is an experienced clinical operations leader and one who contributes meaningfully to CND's clinical study strategies and drives the execution of studies across the Company's portfolio. The Director has spent at least 10-15 years overseeing the successful execution of multicenter clinical studies inside a diagnostics, device, or pharmaceutical company, or as a reliable member of a contract research organization. He or she has demonstrated confidence and competency in managing multiple studies at once, helping to ensure study budgets, timelines, and goals are met. The Director works closely with managers and staff in the R&D department and other functions of the organization to establish study objectives, protocols, milestones, budgets, and other elements and applies his or her knowledge in different areas of study management, including clinical data management, site coordination, patient enrollment, etc. to lend skills and capacity to given projects. The Director collaborates regularly with important Company stakeholders including the Chief Medical Officer, Pathology Team, Laboratory Director, physician co-founders, and scientific advisors and plays an integral role in executing the highest quality work for study sponsors. He or she provides regular updates to the executive team on the progress and challenges of the Company's study portfolio and manages the department and individual study budgets closely, in conjunction with the Financial Controller and VP of Finance & Strategy. The Director will begin by overseeing a small Clinical Research Team and will play an important role in guiding its growth and capacity expansion.

Job Responsibilities:

General

  • Contribute to and exhibit best practices in study design and execution and manage the company's live portfolio of projects.
  • Manage and collaborate with an evolving staff of clinical project managers, coordinators, and associates to achieve all study requirements and goals.
  • Ensure strong compliance with regulations and protocols.
  • Collaborate with study consultants and sub-awardees and serve as an example for the rest of the team in how work is conducted.
  • Oversee study budgets and timelines and recommend course corrections as necessary.
  • Contribute to publication strategies and communications with outside stakeholders.

NIH and other grant-funded clinical studies

  • Serve as CND's clinical operations leader overseeing the execution of multiple NIH and other large, multicenter, grant-funded clinical studies that are critical to the Company's research and development strategy.
  • Mentor and provide support to Clinical Program Managers (CPMs), overseeing NIH and other grant-funded studies and help ensure projects are executed with the highest quality, on time, and on budget.
  • In collaboration with the CPMs, create effective project summary templates and reports and communicate progress and metrics on a regular basis with other Company leaders.
  • Ensure CND maintains compliance with NIH/government grant rules and work with the Financial Controller on budget-related matters.
  • Collaborate closely with the CSO, CMO and other leaders on the achievement of study aims.
  • Maintain key relationships with study sponsors, partners, and vendors.

HEOR studies and patient registries

  • Manage all aspects of assigned CND clinical studies that seek to generate evidence on the clinical utility, quality, economic impact and other benefits of CND's diagnostic technology in a real-word practice setting.
  • Work with CND's medical and scientific leaders, along with outside reimbursement consultants, to define study objectives and create appropriate protocols.
  • Collaborate on data definition and collection strategies and play a key role in database creation and management.
  • Oversee the entire study execution and management process.
  • Collaborate closely with HEOR study sites and any outside vendors.
  • Help define patient registry opportunities and oversee the creation and execution of registry partnerships.
  • Ensure studies meet the highest quality standards.

Knowledge, Skills & Experience:

  • 10-15+ years of experience in clinical research activities within leading life science companies including biopharmaceuticals, diagnostics/medical devices, and/or clinical research organizations.
  • Successful roles leading multidisciplinary teams across geographies and serving as a department head, mentor, and coach to staff.
  • Core expertise in the execution and oversight of various types of clinical studies including clinical utility, validation, health economics, and others.
  • Clear success collaborating with outside study partners and clients.
  • Excellent collaboration and communication skills and ability to present to company colleagues, leaders, investors, and clients.
  • Knowledge and experience in neuroscience with hands-on scientific development work a plus.
  • Understanding of the roles diagnostics and biomarkers play in the current and future landscape of neurodegenerative diseases and proven ability to help translate science into effective research and eventual product development.
  • Strong interest in working in a start-up environment and the ability to take on a range of work at once.
  • Proven attention to detail and a commitment to quality work, including achieving assigned timelines for deliverables.
  • Proactive work style and willingness to take initiative.
  • Professionalism and dedication to respecting colleagues, customers, partners, vendors, and other stakeholders.
  • Strong familiarity and dexterity using IT tools including the MS 365 suite, eDC solutions, and other technology

Education, Certifications & Licensures:

  • Bachelor of Science degree from a reputable college or university
  • Nursing degree, MPH, Ph.D, or MBA a plus but not required

Special Training:

  • Clinical trial and project management certifications preferred

Other:

  • Periodic travel to industry clients, research partners and other locations
  • Travel to conferences 1-3 times per year
  • Combination of seated and standing work to complete the core functions of the role
  • The position is based at the Company's Scottsdale, AZ headquarters with an in-office requirement of 3-4 days/week