Clinical Director Associate

4 hours ago

Merthyr Tydfil, Merthyr Tydfil, United Kingdom Simbec-Orion Full time
About Us

Simbec-Orion is a dynamic and agile full-service Contract Research Organization (CRO) with a strong therapeutic focus and specialist expertise in clinical pharmacology, oncology, and rare diseases. Our team is dedicated to delivering tailored and scalable solutions that meet the unique needs of our clients.

The Role

We are seeking an experienced Associate Clinical Director to join our Medical-Clinical Pharmacology team. As a key member of our team, you will be responsible for ensuring the safe and successful execution of clinical trials, while maintaining the highest standards of data integrity and participant safety.

Key Responsibilities
  • Ensure the safety and welfare of trial participants and the delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with Simbec-Orion's Quality Management System, ICH-GCP, and regulatory requirements.
  • Assess and develop key trial documents and reports, including study protocols, risk management plans, and safety reports, and advise/present on project safety, feasibility, and operationalization.
  • Perform screening, ongoing monitoring, and post-study clinical examinations, including review of ECGs, vital signs, and laboratory results, and report any clinically significant abnormal results to the designated Study Principal Investigator, Senior Medical Director, and/or Sponsors.
  • Evaluate participant eligibility and obtain written informed consent for inclusion in a specific study, according to the information in the Investigator Brochure, Protocol, and Informed Consent Document.
  • Act as a Principal Investigator (including First in Human) / Sub-Investigator for clinical trials, actively participating in data review and taking responsibility for trial decisions, and liaison with hospital specialists, GPs, consultants, and others to recruit suitable volunteers and patients for clinical trials.
  • Be proficient in Advanced Life Support and capable of dealing with acute medical emergencies that may arise in the Clinic Pharmacy Unit, providing medical cover outside of normal working hours as part of an On-Call Rota.
  • Line manage Research Physicians and provide leadership support and guidance to the Heads of Departments for the Clinic and Enrolment Services departments to fulfill their roles successfully, deputizing for the Senior Medical Director.
  • Participate in Commercial Development activities, including feasibility assessment and budget reviews, and take an active role in providing feasibility and strategic advice for proposal development at key client meetings and Bid Defence Meetings.
  • Collaborate and consult with others to develop and maintain strong working relationships with peers, senior leaders, and key stakeholders to ensure projects are delivered on schedule and within budget.
Requirements
  • Medical Degree with GMC Registered with a License to Practice and comply with revalidation requirements.
  • Post-graduate Qualification in Clinical Pharmacology/Pharmaceutical Medicine (eligible to be First-in-Human Principal Investigator).
  • Experience in the conduct of Clinical Trials in a Clinical Pharmacology Unit.
  • Experience as Principal Investigator of FiH studies, including significant experience in the interpretation of non-clinical data.
  • Thorough understanding of MHRA Phase I Accreditation requirements.
  • Excellent verbal and written skills, with the ability to tailor communication to various stakeholders.
  • Experience managing participant safety (eligibility, ongoing review/assessment) and managing Medical Emergencies.
  • Competent in MS Office Packages.
  • Understanding and meeting the needs of clients and the business.
  • Strong leadership, line management, and teamwork skills.
Desirable
  • Valid Advanced Life Support (ALS) certificate from the Resuscitation Council (UK).
  • Previous Bio-Tech /Pharma Experience.
  • Experience in leading cross-functional project/clinical teams.
  • Competent in using Electronic Data Capturing Systems.
  • Experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings.
  • Experience with Clinical Trial Management Systems (CTMS).
Why Join Us

Simbec-Orion is a growing company with a passion for innovation and a commitment to delivering exceptional results. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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