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 Simbec-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 Simbec-Orion's projects.
- Develops interactions with Key Opinion Leaders and investigators in therapeutic areas of interest to Simbec-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
- Background in Dermatology or Neurology, with demonstrable clinical experience in one of these therapeutic areas
- 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:
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.