Offer summary

Qualifications:

Medical Degree is required., Experience in medical monitoring and clinical research is essential., Previous leadership experience in a Medical or Safety Department is necessary., Strong communication skills and proficiency in MS-Office products are important..

Key responsibilities:

Lead and manage the Medical Department ensuring compliance with SOPs.

Act as a point of contact for medical and safety issues during clinical studies.

Participate in all stages of Clinical Trial Development and provide ongoing medical support.

Support business development activities and maintain relationships with Key Opinion Leaders.

Job description

Our Mission

Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.

We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.

The Role

We are looking for a Medical Director to join our Medical - Clinical Development team where you will lead and manage the Medical Department ensuring that Clinical Trials are conducted such that subjects' rights, safety and wellbeing are protected and that the Clinical Trial data is reliable. You will assume Medical responsibility for Clinical Studies conducted by SimbecÃ¢â‚¬â€˜Orion and will provide interpretation of clinical data.

You will work collaboratively with cross-departmental medical monitoring activities (e.g. clinical operations; project management; pharmacovigilance; business development; biometrics; regulatory and technical writing) to drive best practice across the organisation.

Key Accountabilities

Leads and manages the Medical Department, reviewing the department's quality of medical tasks, ensuring that standard operating procedures are followed.
Serves as point of contact for both internal and external stakeholders for issue escalation of any medical and safety issue in the study.
Ensure that departmental SOP's are reviewed on a regular basis to ensure they comply with the latest changes in regulations and guidelines.
Acts as Medical Monitor for assigned trials.
Participates in all stages of the Clinical Trial Development process, e.g., feasibility assessments, protocol design, case report form design, investigational site selection, medical monitoring plan development, ongoing medical support, management of AE's and SAE's, and involvement in trial-related meetings.
Ensures audit queries are responded to.
Ensures Medical and Patient narratives and safety update reports are generated.
Resolve general department CAPAs, escalations and cascade any audit findings to the study team during monthly department meetings.
Provide therapeutic area support throughout the organisation, including the provision of required internal training and review of study/bid proposals.
Maintain knowledge of trends and changes of importance in the medical management of indications, regulations and guidelines relevant to SimbecÃ¢â‚¬â€˜Orion's projects.
Develops interactions with Key Opinion Leaders and investigators in therapeutic areas of interest to SimbecÃ¢â‚¬â€˜Orion as a resource of specific information on indications, patient treatment, and safety assessment for ongoing studies and support business development activities.
Supports the Pharmacovigilance department in reviewing ICSRs, CIOMS narratives, and periodic safety reports and identifies and communicates emergent safety aspects and trends to the Clinical Project Teams and client.
Ensures that Clinical Trials conducted by Simbec-Orion meet the relevant regulations and guidelines and are conducted to the highest ethical standards.
Supports in business development activities, e,g, proposal requests, feasibility and site contact, and attendance at bid defence meetings.
Liaise with other functions in order to ensure client satisfaction through successful execution of clinical projects.
Review annual departmental budget and provide continuous oversight/control.

Skills Required

Essential

Medical Degree
Experience in medical monitoring, review of patient, laboratory, and safety within a clinical research environment
Previous experience of leading a Medical and/or Safety Department
Significant experience in audits and CAPA management
Significant experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings
Understanding of financial project management, including departmental budget oversight and revenue recognition
Professional communication and presentation skills
Strong computer skills including but not limited to the knowledge of electronic data capturing systems and MS-Office products such as Excel and Word

DESIRABLE

GMC Registered with a License to Practice
Post-graduate Qualification in Clinical Pharmacology / Pharmaceutical Medicine
Pharmacovigilance experience
Experience working in a CRO, biotech or pharmaceutical company

About Us

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