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 an Associate Medical Director to join our Medical - Clinical Development team, where you will assume medical responsibility for clinical studies conducted by Simbec-Orion and is responsible for the clinical interpretation of data and to ensure clinical trials are conducted such that subjects' rights, safety and wellbeing are protected and that the clinical trial data are reliable. Assists in cross-departmental medical monitoring activities and works with the wider cross-functional team that include Clinical Operations, Project Management, Pharmacovigilance, Business Development, Biometrics and Regulatory and Technical Writing.
Key Accountabilities:
- Acts as Medical Monitor for more complex 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.
- Responds to study specific audit queries and supports in the resolution of the audit findings.
- Supports the Medical Director in resolving general department CAPAs, escalations and cascading any audit findings to the study team during monthly department meetings.
- Generation of protocol and synopsis writing with sponsor and Technical Writing team.
- Review Clinical Study report and provides feedback to the Medical and Technical Writing team.
- Generates Medical and Patient narratives and safety update reports.
- 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 the development of Standard Operating Procedures to drive best practice across the Medical Department.
- Interprets Clinical and Pharmacovigilance data (including the coding of clinical data and the review of relevant safety reports) to identify any potential safety concerns and advise the study team accordingly.
- Supports in business development activities, e,g, proposal requests, feasibility and site contact, and attendance at bid defence meetings.
- Supports the study team in reviewing audit findings that require medical input and communicates to the Head of the Department to apply corrective and preventive actions.
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
- Experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings
- Excellent organisation and time management skills. Ability to effectively manage any changes to priorities/deadlines
- Experience in Regulatory and sponsor audit and resolving CAPAs.
- Experience in Pharmacovigilance process, including medical review.
- 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
- Previous experience of working within a small/mid-size CRO, biotech or pharmaceutical company
- Proven experience in building effective relationships with external clients and sponsors
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.