Job details:
We are seeking an Associate Medical Director to join our on-site Medical-Clinical Pharmacology team. In this role, you will ensure the safe and effective design, execution, and delivery of projects to meet clients' development requirements while maintaining the safety and welfare of trial participants and data integrity within the Clinical Pharmacology Unit.
Your responsibilities will include ensuring that all procedures comply with Medical, Scientific, and Ethical Standards, and that all trials adhere to protocols, standard operating procedures (SOPs), and regulatory requirements, including ICH-GCP. You will manage the Research Physician team, share knowledge, support the team's competency, and serve as Principal Investigator for studies, including First-in-Human Trials.
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Safeguard trial participants' safety and welfare while ensuring the delivery of high-quality studies in accordance with Simbec-Orion's Quality Management System, ICH-GCP, MHRA Phase I accreditation requirements, and The Independent Health Care (Wales) Regulations 2011.
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Develop and assess key trial documents and reports, including study protocols, Risk Management Plans, study-specific training, and safety reports. Provide safety, feasibility, and operational advice both internally and to clients.
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Conduct screening, ongoing monitoring, and post-study clinical examinations, including reviewing ECGs, vital signs, Spirometry, Holter, and laboratory results. Manage and assess adverse events, reporting significant results to the designated Study Principal Investigator, Senior Medical Director, and/or Sponsors.
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Evaluate participant eligibility and obtain written informed consent in line with the Investigator Brochure, Protocol, and Informed Consent Document.
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Facilitate effective communication with volunteers' General Practitioners regarding their study participation, collaborative care, and follow-up.
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Act as Principal Investigator or Sub-Investigator for clinical trials, ensuring high standards, participating in data review, and making trial decisions, including dose escalation. Liaise with hospital specialists, GPs, and consultants to recruit suitable volunteers and patients.
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Be proficient in Advanced Life Support and manage acute medical emergencies in the Clinic Pharmacy Unit. Provide medical cover outside normal working hours as part of an On-Call Rota.
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Manage the Research Physicians, offering leadership support and guidance to the Heads of Departments for Clinic and Enrolment Services. Deputize for the Senior Medical Director as needed.
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Engage in Commercial Development activities, including feasibility assessments and budget reviews, and offer strategic advice for proposal development at client meetings and Bid Defence Meetings. Represent Simbec-Orion at national and international conferences, seminars, and workshops.
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Collaborate with peers, senior leaders, and key stakeholders to develop and maintain strong working relationships, ensuring projects are completed on schedule and within budget.
Required Skills
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Medical Degree: Must possess a medical degree and be registered with the GMC, holding a valid License to Practice, and comply with revalidation requirements.
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Post-graduate Qualification: Should have a post-graduate qualification in Clinical Pharmacology or Pharmaceutical Medicine, and be eligible to act as a First-in-Human Principal Investigator.
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Clinical Trial Experience: Must have experience conducting clinical trials within a Clinical Pharmacology Unit.
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Principal Investigator Experience: Significant experience as a Principal Investigator for First-in-Human studies, including the interpretation of non-clinical data.
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Regulatory Knowledge: Comprehensive understanding of MHRA Phase I Accreditation requirements.
Must be able to come to the office, as this is an on-site role