Director, Clinical Operations

The Director, Clinical Operations (DCO) will act as functional program lead reporting directly to the Head of Clinical Operations. Responsible for the planning, execution and conduct of commercially sponsored clinical trials as well as oversight of any investigator-initiated trials being conducted. Trials are to be executed on time, within budget, compliant with all relevant regulatory and ethical requirements, and be of the highest quality to support submission to relevant authorities for drug approval.

Key Responsibilities:

  • Delivery on all clinical operational aspects of assigned clinical trial/s ensuring compliance with all applicable laws and regulations, company Standard Operating Procedures (SOPs), study contracts, budgets and timelines from start up through to clinical study report
  • Primary interaction with internal and external cross functional teams and key stakeholders, ensuring clinical trial and department objectives are met
  • Development of Request for Proposals (RFPs) and scope of services for outsourced clinical activities
  • The assessment and selection of Contract Research Organisations (CROs)/other vendors, seeking input from other internal functional updates and ensuring qualification of vendors in accordance with company SOPs
  • Oversight of CROs/vendors by serving as primary contact, problem resolution and defining Key Performance Metrics
  • Tracking of project deliverables using appropriate tools incorporating risk management
  • Prepare reports for management on program status and issues
  • Interact and establish relationships with clinical trial investigators, key opinion leaders, DSMBs, Scientific Advisory Board members and development partners
  • Writing and coordinating review of key documents, including but not limited to protocols, subject information sheets/informed consents, case report forms, study plans and clinical study reports
  • Coordination of audits as required, responding to CAPAs and ensuring trials are always Inspection Ready
  • Involvement in general Clinical Operations department initiatives/activities including reviewing SOPs and input into process improvements  
  • Provide support and training for other staff members on specific areas of expertise
  • Contribute to other Clinical Operations and R&D Department/company activities and initiatives as required

Skills and Attributes

  • Minimum of a Bachelor’s degree in life science, medical, or related field
  • Relevant clinical operations experience within pharmaceutical/biotech/CRO industry
  • Considerable experience overseeing CROs and/or other vendors
  • Excellent organisational, analytical, planning and project management skills
  • Demonstrated ability to prioritise multiple competing tasks
  • Strong scientific background and prior experience in relevant therapeutic area preferred
  • Effective communication skills and cross functional collaboration skills
  • Excellent knowledge of Good Clinical Practice, ICH guidelines and appropriate regulations
  • Ability to work independently and within small teams
  • Self-starter and team player who thrives in a fast-paced environment

Role Requirements

  • Permanent, full time position
  • UK home-based, with a requirement to travel to office in Cardiff, Wales every 4-6 weeks and travel domestically/Internationally as necessary for the clinical program/s
  • Will lead a global phase III study in an orphan indication so experience in later phase studies essential
  • Therapeutic Areas (GI/oncology) preferred but not essential

No recruitment agencies please.

Job Title

Director, Clinical Operations

Reports To

VP, Head of Clinical Operations

Location

UK home-based, with a requirement to travel to office in Cardiff, Wales every 4-6 weeks and travel domestically/Internationally as necessary for the clinical program/s

How to Apply

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