Clinical Director Associate

1 month 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 extensive experience 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 well-being of trial participants and the delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with Simbec-Orion's Quality Management System and regulatory requirements.
  • Assess and develop key trial documents and reports, including study protocols, risk management plans, and safety reports, and advise on project safety, feasibility, and operationalization.
  • Perform screening, ongoing monitoring, and post-study clinical examinations, and report any clinically significant abnormal results and/or changes from baseline.
  • Evaluate participant eligibility and obtain written informed consent for inclusion in a specific study.
  • 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.
  • Provide 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.
  • 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.
Requirements
  • Medical Degree with GMC Registration and a License to Practice.
  • Post-graduate Qualification in Clinical Pharmacology/Pharmaceutical Medicine.
  • 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 and 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.
Why Join Us

Simbec-Orion is a growing company with a passion for innovation and patient care. 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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