Research & Development Institute, Inc.
  • Los Angeles, CA, USA
  • Full Time

Research & Development (RDItrials.com) is a research laboratory and biobank that serves as a Contract Research Organization to the largest In Vitro Diagnostic companies (Laboratory Medical Device Manufacturers) in the industry. RDI manages between 20-40 sample collection and validation studies a year and have supported 120+ assays through the FDA (510K, PMA, and De Novo) and CE regulatory pathways.

The Senior VP - Clinical Operations will be a member of the executive management team responsible for building and leading a high performing team that manages and conducts all of our Clinical Trial operations. He/she will also be able to solve problems with improved systems today and then be
able to foresee challenges that may arise from scaling and proactively eliminate them.

He/she is responsible for overseeing both Business Development and Operations to understand and match our client's needs for biological samples and or lab equipment with our network of physicians and labs. He/she will drive the sales process to convert client's requests into signed clinical trial projects and then ensure that our operations are conducting high quality, inspection ready studies that adhere to Good Clinical Practices.

The Senior VP - Clinical Operations is first and foremost a servant leader to the operations team and devotes his/her attention to our clients and the conduct of their clinical trials, our physicians and lab partners. This includes overall responsibility for design and successful execution of clinical studies under adherence to GCP and other regulatory requirements. The position will manage a multisite team that includes senior managers with their teams of clinical project managers and Clinical Research Associates (CRA) as well as administrative support staff.


Responsibilities

  • Work with our clients in R&D and Clinical Affairs to understand their sample and instrument
    testing needs and identify ideal physicians and labs in our network
  • Develop executable Statements of Work for clients that clearly outline all deliverables and
    priced to hit company profit margins
  • Source samples and instruments quickly for our clients by working with the Operations
    Director and Project Manager to conduct feasibilities with physicians and labs quickly
  • Push all projects forward, identify roadblocks and remove them. You will ruthlessly
    prioritize projects and use creative problem solving that the team may not see to get our projects
    completed quickly.
  • Lead the development, review and implementation of departmental SOPs and processes.
    Clinical Trials are a regimented process but there is ample room to improve and make our
    processes more efficient.
  • Provide mentorship and career development to direct reports. Be a servant leader to the
    growing organization.
  • Earn and maintain the trust of our clients and physicians. You will also direct resources to
    expand our network of physicians and labs.
  • Staff projects appropriately, understanding when to flex up or down on staffing needs, in line
    with business objectives
  • Identify and recruit new 'stars' incrementally - in step with expected revenue growth
  • Site Health: work with site director to assist in expanding our network of physicians and labs
    but also to ensure their interactions with RDI are high quality and encourage them to continue
    working on our studies in the future

What we look for

  • Clinical Trials Experience: experience and knowledge of clinical lab operations and the assay
    development process from R&D, through clinical trials, and post-marketing
  • Diagnostic Industry Experience: 7+ years of management position in IVD, life sciences or
    medical device industry, or CRO; In-depth understanding of clinical trials, and common IVD
    product development processes and requirements.
  • Systems-first Problem Solving approach: an ability to solve problems as they occur but
    develop solutions to prevent them from occurring again.
  • Clinical Trial Software Fluency: understands critical software used to conduct Clinical Trials
    (eTMF, eCRFs, 21 CFR Part 11 compliant) as implementing technological solutions is critical to
    our ability to scale
  • Site Health: work with site director to assist in expanding our network of physicians and labs
  • Entrepreneurial leader mindset: high IQ and EQ, takes pride in being an excellent problem-solver. Leader who is excited to do the hard work to establish (and sometimes re-establish) the foundation of a growing business and support the team along the way
  • Financial and Contract Acumen: an executive with an MBA or similar background to be able to
    price projects, negotiate site/vendor contracts
  • Hustle: Comfortable in a fast-paced small company environment and able to adjust workload
    based upon changing priorities
  • Diplomat: broker agreement across the company and with partners or stakeholders; is a
    respected member of the team; strong motivator; approachable; entrepreneurial, while hitting
    the numbers
  • Track Record of Success: has beaten success metrics 90% of the time throughout his/her
    career; performance reviews are in top echelon; promotions were earned faster than most
Research & Development Institute, Inc.
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