Sr Manager/Assoc Director, Clinical Development (IVD Studies) – NC Biotech/Remote

Job Type: 
Life Sciences
Data Management, Biostatistics and Programming
Business Management and Operations
Clinical Research and Development
Scientific Research and Lab Operations
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, an NC-based biotechnology company that is developing a precision oncology platform that will help guide oncologists’ treatment plans for their cancer patients, is actively recruiting for a highly skilled and knowledgeable Clinical Research leader to drive all Clinical Development and Operations efforts.

 

This is cutting-edge, paradigm-shifting technology that will transform cancer care in diagnostics. 

 

It uses patient-derived micro-tumors (biopsies) for rapid therapeutic profiling for oncology patients.  It will also contribute to drug development and discovery in industry.  The company is supported by

investments from top precision medicine companies and the future is very bright.

 

This Senior Manager / Associate Director (client is open to both levels) will oversee all aspects of these IVD clinical studies. It is a critical role and company will pay excellent wage to attract and retain the right candidate.

Things to Note:

  • This position can be remote, anywhere in the US.  Company is also open to relo to its NC site.
  • This SM/AD will be the Subject Matter Expert for the company, and will plan, execute and oversee all Clinical Research efforts.  Seek candidate who combines both clinical development and clinical op’s experience.  Sponsor experience will be important.  IVD experience (or very similar) is required.
  • The company will employ CROs for early trials.  Experience overseeing CROs is assumed and required.  Experience at the feasibility stage is highly preferred.
  • Sites are primarily domestic.  International sites will be added in the short-term
  • Studies will comply with the FDA guidelines for an investigation of a non-significant risk device. Seek candidate familiar with the abbreviated Investigational Device Exemption (IDE) requirements under 21 CFR 812.2b.
  • This company is in start-up mode.  Right candidate will be a hands-on doer who works effectively and strategically without a blueprint.
  • This is an emerging company in which processes, practices and protocols are still being developed. Seek resourceful, flexible, versatile and can-do candidate who will work well in this entrepreneurial setting.

Selected Responsibilities:

  • Develop and set up critical study documents, plans and systems for the product development phase supported by applicable studies
  • Develop risk-based monitoring and project management plans as appropriate for applicable studies
  • Manage and lead the day-to-day operations of IVD studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with study vendor team
  • Manage and lead cross-functional study teams and liaise with other functional areas in order to accurately coordinate clinical study activities
  • Coordinate clinical study timelines with project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
  • Review monitoring visit reports and perform monitoring oversight visits as needed
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
  • Lead feasibility assessment and selection of countries and sites for study conduct
  • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
  • Coordinate with finance to track the financial status against budget

Targeted candidate will offer a related degree and 5+ years of clinical trial management experience, including several years working directly for a sponsor.  IVD is strongly preferred but client will also consider candidates with extensive experience with non-significant risk device trials.

Other priorities include:

  • Substantial knowledge of and practical experience with protocol and clinical IVD development processes, clinical study design for IVD development, study planning and management, and risk-based monitoring
  • Familiarity with Abbreviated Investigational Device Exemption (IDE) requirements under 21 CFR 812.2b
  • Ability to effectively guide, manage and develop quality relationships with CROs and other vendors
  • Outstanding project management and planning skills
  • Strong troubleshooting and problem-solving abilities
  • Demonstrated ability to lead cross-functional teams and guide disparate groups towards a shared goal
  • Record of achievement, growth and longevity in previous roles

Finally, we seek an industrious, resourceful, focused and collaborative leader who will thrive in this growing setting.

This is an immediate need.  Please forward Word resume for prompt consideration. Local candidates only.