The European Medical Director will provide medical support in Europe for Soligenix-sponsored clinical programs initially focusing on the company’s ongoing Phase 3 clinical program. This will included supporting Soligenix’s CRAs, European clinical study centers, and Soligenix partners as well as providing the initial European pharmacovigilance oversight and regulatory compliance. They will help ensure the regulatory and scientific integrity of all studies performed in Europe, the UK, and other non-American countries. This position will help evaluate, monitor and audit, and document all study information arise in Europe including fostering excellent relationships, and contact with site personnel, clinical operation personnel, and the Soligenix management team based in the United States.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
- Provides detailed medical support for all aspects of the clinical trials conducted by Soligenix including protocol design, site selection, study site training, adverse event review, safety reviews of clinical data, and initial serious adverse event reporting,
- Participates in clinical team meetings; co-leads discussions regarding medical issues with US counterpart.
- Prepares and reviews a variety of documents including protocols, CRFs, informed consent forms, operations manuals, and other documentation required for the conduct of a clinical trial.
- Identifies potential investigators and will work with the European clinical operation and USA management teams to assess and select sites that are assessed to be capable of adequate recruitment and generating high quality study data. This will be accomplished by telephone, site visits, and discussions with the CRA(s) assigned to the site.
- Will review the initial budget and clinical trial contracts from all European sites approved to participate in Soligenix clinical trials.
- Will monitor the quality of the European clinical trial data by telephone, site visits, discussions with the CRA(s) assigned to the site, and review of ongoing and final data in the electronic case report forms.
- Will provide medical support for clinical sites, regulatory agencies, and clinical operation personnel in Europe on a 24/7 basis.
- Will monitor during and at the conclusion of each clinical trial all safety information- including adverse event reports, serious adverse event reports, and health authority fillings for all patients enrolled in Europe.
- Will monitor the critical primary outcome data, real time, for all clinical trial data from Europe for accuracy and consistency.
- Participates in conducting investigator meetings, including advance preparation, presentations, problem resolution, and follow-up.
- Identifies, analyzes, and reports serious compliance issues, and develops action plans for approval by management. May conduct monitoring or accompanied oversight visits to resolve difficult study conduct issues.
- Reviews data tables, listings, and study reports for assigned protocol(s).
- Conducts oversight visits to CROs throughout the life of the trial and in preparation for inspection.
- Review and revise all clinical study related SOPs, procedures, and policies to assure compliance of these documents to all appropriate European rules, guideline, and regulations.
- Support operations to ensure that the study is being conducted in compliance with the GDPR for Europe.
- Performs other duties as assigned, including continuing to successfully perform functional responsibilities of medical director.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Bachelors degree in a health science field or nursing degree, doctorate preferred.
YEARS OF EXPERIENCE:
- Minimum of 7.5 years of experience in the pharmaceutical industry and 5 years of clinical trial monitoring experience.
- Experience in working on at least 2 multicenter, international, Phase 2 clinical studies and 1 Phase 3 clinical study.
- Experience working in the clinical settings of oncology.
- Experience in submitting Clinical Trial Authorizations in multiple European countries, successful Ethical Committee submissions in multiple European countries, presentations to EMA and local Health Authorities, and preferably, submission of at least 1 MAA.
- Working knowledge of local and regional requirements for initiating clinical studies in the critical countries in West, Central and Eastern Europe.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
- Must be able to travel up to 40% of the time, when needed, including 2-4 trips to the USA per year.
OTHER SKILLS AND ABILITIES:
- Requires comprehensive knowledge of the pharmaceutical clinical development process and applicable regulations and guidelines.
- Solid understanding of the roles and responsibilities of all functional areas in the extended project team.
- Knowledge of GCP/ICH and applicable regulatory requirements.
- Strong communication, organizational and planning skills.
- Strong computer skills with demonstrated experience in working with Microsoft Office programs (Word, Excel, PowerPoint, and Outlook).
- Strong problem solving and analytical skills.
- Excellent English and preferable fluency in several European languages.
How to Apply
Please provide resume, references, and current location via e-mail to email@example.com. Compensation will be commensurate with experience. No phone calls, please. No recruiters.