Senior Medical Director, Oncology (UK/EUROPE) - Novella Clinical
Novella Clinical is looking for a leader and outstanding Senior Medical Director to join the expanding European Medical Affairs department. This is a new position within the European team to specialise in our market leading Oncology vertical.
Oncology is an ever-growing part of the Novella business as we continually succeed in winning business and delivering cutting edge services in this area. For this reason, we need to bring in experts to bolster the already expert group of Oncologist within the organisation.
The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by Novella Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Novella Medical Monitor also works as Medical Safety Reviewer in conjunction with Novella Safety Management, and provides Medical Data Review in support of Data Management. The Novella Medical Director may also provide support for the acquisition of new business by participation in the bid defence process with medical review of proposal text, and by preparing for and attending bid defences.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting
- Ensures medical activities run according to GCP and operate with highest efficiency
- Establishes and maintains a network of medical/scientific consultants, etc.
- Supervises and manages Medical Director activities
- Interacts with clients regarding drug development programs, study design and protocol
- Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.
- Provides project team training on protocol and/or therapeutic areas
- Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
- Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations
- Presents protocol and/or safety reporting information at investigator meetings
- Develops project medical monitoring plans as requested
- Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
Safety Monitoring and SAE Reporting Activities:
- Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study
- Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed
- Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data
- In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)
- Interact with appropriate FDA officials concerning safety and other study related issues, as requested
For a full job description and more information on the role and company please feel free to apply via the website, email me directly (firstname.lastname@example.org) or contact me on LinkedIn. I would be more than happy to discuss this in more detail if you feel your suitable for the position.
I look forward to receiving your application,