Clinical Research MD (m/f/d)

REFERENCE NUMBER:

597876/1

MY DUTIES:

- Conducts medical data review of trial data, including eligibility review
- Responsible for site interactions in partnership with the SRS for medical questions and education (including safety management guidelines)
- Responsible for assessment of key safety-related serious adverse events in partnership with the Local Safety Officer and the Medical Safety Officer and oversees safety narratives
-Collaborates with the SRS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations)
- Fulfills GCP and compliance obligations for study conduct and maintains required training
-In collaboration with the leadership and other cross-functional team members, executes CDP, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of the asset/drug, disease area, and relevant science to meet regulatory and disease strategy targets
- May lead study Steering Committees (together with Clinical Leader)
- Leads the analysis of benefit/risk for clinical study protocols in a matrix team environment working in partnership with SRS
- Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations, etc.).
- Builds relationships with Investigators and supports study site selection. Partners with key opinion leaders (KOLs) to gain their input on emerging science in drug and biomarker research, disease knowledge, and design of clinical studies and programs
- Maintains a strong medical/scientific reputation within the disease area. Has in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up to date in the disease area via attendance at scientific conferences and ongoing review of the literature
- Provides ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and others

MY QUALIFICATIONS:

- A Medical Degree is required
- Industry and prior experience with clinical development/clinical studies is preferred
- Clinical experience in cardiology or pulmonology area is highly preferred
- Prior experience managing projects with clinical trials including development of protocols, case report forms, informed consent, study initiation, protocol training, and clinical data monitoring is preferred
- Excellent written communication, oral communication, and presentation skills are required
- The individual must have demonstrated ability to work and lead in a cross-functional and matrix team environment, working with external stakeholders and be flexible and adaptable

MY BENEFITS:

- Exciting tasks in an international pharmaceutical company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.