Medical Advisor Clinical Trials 002
2 weeks ago
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
**This is what you will do**:
The Medical Advisor Clinical Trials (MACT) is a field-based scientific resource that strategically supports the development, medical and scientific objectives of Alexion’s products in the different phases of development.
The MACT will work very closely with Country Operations, Clinical Operations & Clinical Development to ensure successful delivery and performance of Alexion’s clinical trials. The MACT will also act as a peer scientific expert who communicates accurate and applicable scientific and medical information to Principal Investigators and Key Opinion Leaders (KOLs) and collects relevant data for Alexion from the field within a geographic area. In addition, the MACT will manage and maintain collegial and professional relationships with HCPs and identifies and facilitates collaboration opportunities with Alexion in new fields of engagement.
As Country Operations team member the MACT will maintain a very close collaboration with the Medical Affairs teams and especially with the New Product Medical Leads (Advisors). This includes regular bi-directional updates and alignment for each individual study.
The MACT will report directly to the Regional Head, Country Operations, Americas and dotted line to the Head of External Scientific Engagement.
**You will be responsible for**:
- Developing and maintaining the highest scientific and medical expertise in the relevant fields and be acknowledged internally and externally as an expert and resource in the assigned therapeutic areas
- Developing in depth knowledge of the assigned therapeutic areas, in terms of sites, physicians, laboratories, networks, and current diagnostic and clinical practices.
- Ensuring timely and informative scientific/medical exchanges with customers and internal partners, in accordance with compliance policies and with legal requirements, to drive the successful delivery and performance of Alexion’s clinical studies.
- In close partnership with the local Medical Affairs team, drives identification of potential sites and investigators for clinical trials, helping to expand Alexion clinical trial network of sites.
- Building and maintaining strong partnerships with Investigators and other external stakeholders, including professional organizations for trial related activities. When applicable, initiating the work of identifying national or local opinion leaders, in close collaboration with the local medical affairs team.
- Enhancing clinical operations efforts to improve recruitment & retention by providing education and training, as well as clinical discussions with site’s team via early engagement during feasibility and throughout conduct of trial, e.g. on eligibility criteria, barriers to recruitment, etc. In addition, supporting the development and refinement regarding the local patient pathway and definition of recruitment barriers and recruitment drivers on a country level.
- Understanding country landscape and coordinate country input into protocol feasibility re: country and site‘s ability to conduct study, patient burden, SOC, competitive intelligence, etc. Improving clinical trial protocols by coordinating country input, e.g. through Global Project Team (GPT), if required
- Liaising with Country Operations and Clinical Operations to support clinical study feasibility, effective study implementation and study management by proactively engaging investigators and clinical trial sites for the lifecycle of the trial. This may include supporting Country Operation team members and/or Clinical Research Associates during Site Evaluation, Initiation Visits or Engagement Visits, as needed
- Developing and maintaining strong collaboration with, but not limited to: Country Operations Management, Country Medical Affairs teams including the New Product Medical Leads (Advisors), Clinical Operations, Clinical Development and Launch excellence
- Maintaining current knowledge of local laws and guidelines, codes of practices and Alexion policies relevant to Clinical Development and Medical Affairs activity
- Ensuring appropriate and compliant level of Patient Advocacy Organization (PAO) group involvement with Patient Advocacy team
**You will need to have**:
- Scientific degree/ Life Science/Medical degree or proven scientific excellence
- Minimum 5 years of combined experience in Medical Affairs/Clinical Operations/Clinical Development
- Knowledge of the country’s healthcare system and ma
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