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Medical Director

4 months ago

UK, UK, United Kingdom RRxCo.™ Full time

RRxCo is partnered with an ambitious, clinical-stage Biotechnology Company that develops novel medicines for severe immune disorders. This exciting and innovative firm is expanding their team by creating an opening for a Medical Director. Focused in the field of auto-immune disorders, our client is set to develop several assets over the coming years.


Summary

In collaboration with the Chief Medical Officer other functional leaders, you will support the study design, development, execution, data readout, and summary of our client’s pipeline. The role will incorporate both strategic and tactical responsibilities in line with this organizations ambitious milestones.


Working closely with the medical monitor at the contracted CRO, you will also work with the Clinical Science team to evaluate medical safety and scientific data.


This position will be a key contributor for 2-3 clinical programs (Phase II initially), the majority of which are global studies. This position will also provide ongoing assessment and interpretation of safety data and contribute to investigator training.


Working with colleagues in the US and UK, this position will suit an Associate Medical Director (or similar) seeking to progress their career within a start up environment, focusing in the field of rare diseases.


Deliverables


  • Serve as Medical Monitor, responsible for the medical monitoring of clinical trials.
  • Collaborate with external opinion leaders and Principal Investigators, as well as the CRO, to ensure studies are designed appropriately and successfully implemented.
  • Provide medical/clinical support, and scientific opinion to study teams and functional areas (Regulatory, Clinical Development, and Clinical Operations.).
  • Provide input into study design, study protocol, statistical analysis plans, and study readout/reporting to yield high-value clinical endpoints.
  • Review aggregate or individual medical safety reports.
  • Support the development of regulatory documents for filings and agency meetings.
  • Review and interpret scientific knowledge of the competitor landscape.
  • Participate in the preparation of abstracts, manuscripts, and presentations for external meetings.
  • Plan and present at investigator, internal company, and other meetings as required
  • Author clinical sections of regulatory documents (IB and IND sections).
  • Remain up to date with current regulations, guidelines, and practices (ICH-GCP and other external regulations/procedures required for regulatory filing).
  • Remain up to date with therapeutic area knowledge to ensure consistent best practices across all activities.


Profile


  • MD degree with experience of medical monitoring in clinical trials, and broad experience in industry/drug development and/or clinical research.
  • Rheumatology, dermatology or rare disease therapeutic experience from within Pharma, Biotech or CRO is highly desirable.
  • Desirable: Higher degree e.g., PhD.
  • Ability to work with a high level of autonomy.
  • Ability to analyse and interpret clinical safety and efficacy data and develop written reports and presentations of those data.
  • Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
  • Previous experience of working successfully in a cross-functional team.
  • Periodic travel to the London office.
  • Approximately 25% travel.