Director of Clinical Development (Ref 4245)

| Permanent

Artios is currently recruiting a Director of Clinical Development to join our expanding team. This is an excellent opportunity to join a world class research team in a dynamic, expanding biotech company based south of Cambridge, UK. Artios is focused on identifying and developing cancer treatments by exploiting novel targets within the DNA damage response (DDR), a scientific area of high expectation following the success of PARP inhibitors in the clinic. The company is actively working on an exciting portfolio of unique DNA repair projects.

We currently have two programmes in early phases of clinical development. These phase 1/2a studies are evaluating the small-molecule ATR inhibitor ART0380 and the first-in-class Pol Theta inhibitor ART4215 in patients with advanced or metastatic solid tumours.

Reports To:

Vice President of Clinical Development

Job overview:

The Director of Clinical Development (DCD) will be responsible for supporting the VP of Clinical Development in overseeing the project management and clinical operations of clinical stage drug development projects. The DCD will also support the CMO developing and implementing the clinical development plans. This involves leading multiple clinical trials, liaising with CROs and other vendors, and managing the budget, timelines and risk.

Responsibilities and Duties:

The Director of Clinical Development is responsible for:

  • Delivery of clinical studies to time, cost and quality
  • Supporting the VP of Clinical Development in overseeing the project management and clinical operations of clinical stage drug development projects
  • Supporting the CMO in developing and implementing the clinical development plans
  • Managing the selection and oversight of external consultants, Contract Research Organisations (CROs) and other external partners; ensuring all CROs and other vendors are selected according to SOPs and that contracts are in place
  • Development of regulatory documents
  • Management of budget, timelines and risk
  • Ensuring Sponsor responsibilities as per contract are fulfilled
  • Leading clinical operations, liaising with investigators
  • Oversight of clinical CROs and ensuring that studies are managed in compliance with GCP
  • Working with the CMO/VP of Clinical Development to prepare and or review study protocols, consent forms, review case report forms and other study related documents
  • Reviewing and approving study related documents and plans
  • Liaising with third party supplies to ensure compliance
  • Ensuring appropriate ethics and regulatory approvals are in place
  • Reviewing and updating Investigator Brochures in conjunction with relevant personnel
  • Agreeing safety monitoring plans with input from CMO or study physician
  • Monitoring progress of studies, scheduling meetings with CRO and project teams
  • Planning, collaborating on and reviewing scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline
  • Reviewing and summarizing clinical data
  • Assisting CMO in protocol oversight and input into informed consent documents
  • Supporting the monitoring of patient safety during study and participating in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures
  • Collaborating with colleagues and investigators in the design, conduct and reporting of clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions)
  • Reviewing and collaborating with CMO on the approval of risk profiles to ensure to ensure appropriate communication of risk to study subjects
  • With CMO and VP of Clinical Development, leading investigator identification and selection
  • Assisting the CMO in the documentation of the completion of the administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements
  • Leading the planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel
  • Serving as resource to other team members to address any questions or clarify issues arising during the conduct of study
  • Understanding and actively addressing the scientific information needs of all investigators and personnel

 Qualifications:

  • Comprehensive understanding of drug development
  • Extensive experience of clinical study management, preferably oncology studies
  • Competent in use of Microsoft Office
  • Experience budgeting clinical studies
  • Ability to work independently and as part of a team
  • Experience of Quality Management Systems, database applications and project management tools
  • Excellent organisation and time management skills, with the ability to prioritise and multi-task
  • Strong communication, influencing and interpersonal skills
  • Flexible approach to change

This is a permanent position, offering an attractive salary & benefits package. If you have the right background, then please apply using the link below which is via our HR software system.

https://hr.breathehr.com/v/director-of-clinical-development-22681

The closing date Monday 13 June 2022

In order to comply with UK Employment Law, all applicants must have the Right to Work in the UK or if from the EU, subject to receiving a relevant Skilled Worker Visa to work in the UK.

Due to the high volume of applications we receive; if you do not hear from us we will not be inviting you to interview on this occasion.