Head of Clinical Operations


21st July 2021

Specific Responsbilities

Reporting to the CSO, the Head of Clinical Operations will be responsible for the leadership in clinical operations and clinical project management activities at Midatech Pharma’s R&D site in Cardiff, ensuring relevant corporate goals are delivered. As a key member of the Senior Management Team, this role has substantial influence over R&D strategy and development activities.

Essential duties and responsibilities:

  • Create, execute and proactively manage clinical trial processes
  • Establish and drive clinical project management processes, in collaboration with a clinical lead drive project management teams to achievement of milestones within the agreed timelines
  • Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met
  • Establish performance indicators and apply to ensure the successful execution of clinical trials to agreed timelines
  • Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including development plans and study protocols; interact and collaborate with other functions as appropriate
  • Represent all aspects of Clinical Operations and provide updates as required to the senior management, Project Teams, Board of Directors and other key internal stakeholders
  • Lead & mentor Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff
  • Oversee, plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority regulations and patient safety standards
  • Develop a pro-active approach for Inspection readiness
  • Assist the QA team in the development, review and updating of Midatech clinical SOPs and procedures
  • Drive the authorship of operational sections of protocols and investigator brochures, and lead the identification of and interaction with investigative sites and investigators, including study execution
  • Develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects
  • Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans.

Job Factors

Minimum education level Bachelors in Life Sciences, Nursing or Pharmacy degree; an advanced degree (MS or PharmD) is preferred.
Professional experience
  • A minimum of 15 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late stage clinical trials
  • In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection. Therapeutic experience in oncology, neuro-oncology, rare diseases coupled with experience with pivotal, multi-site clinical trials is highly desirable but not mandatory
  • Experience with global drug development and NDA/MAA filing is preferred; experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
  • Experience with clinical data management and pharmacovigilance is a plus.
Other experience
  • Proactive problem solving abilities and follow-through
  • Strong communication and presentation skills.
  • ‘Can do’ hands-on attitude. This is a fast paced small organization. The ability to be productive and successful in an intense work environment is critical.
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA/EMA/MHRA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods. Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws
Other

This position may be remote with only periodic visits to the Cardiff office of the company or may be fully office-based

Legally authorised to work in the UK

Job Title

Head of Clinical Operations

Salary

negotiable

Reports To

Chief Scientific Officer

Location

remote or Cardiff, UK with travel as required

How to Apply

To apply for any vacancies listed please submit your CV and a cover letter to: careers@midatechpharma.com