Study Physician (Medical Responsible)
We are now looking for a Study Physician for Cinclus Pharma!
Cinclus Pharma is a Swedish clinical-stage pharma company developing small molecules for the treatment of gastric acid-related diseases. Their lead candidate linaprazan glurate is being developed for the treatment of moderate to severe gastroesophageal reflux disease (GERD). At Cinclus Pharma, you'll be part of a dynamic, fast-growing company and have an exciting role where your contributions will directly impact the company's growth and success.
As a Study Physician at Cinclus Pharma, you'll take the lead in medical oversight for their clinical studies, ensuring they are conducted to the highest standards. You'll be the medically responsible physician for assigned studies and work closely with cross-functional teams, CROs, and regulatory authorities to ensure safety, quality, and compliance throughout the trial process. A part of your role will be presenting findings and clinical results to both internal teams and external stakeholders, so strong presentation skills are essential.
Responsibilities
- Serve as part of the CMO medical team.
- Serve as medical team leader on assigned projects.
- Act as the sponsor’s medically responsible physician for the studies assigned.
- Provide medical oversight monitoring for clinical studies.
- Medical oversight for serious adverse event reporting and tracking, and communication of safety issues to CROs and vendors involved, other sponsor representatives, and regulatory authorities.
- Medical oversight to screening process and decisions and review of medical and laboratory data.
- Provide medical support and advice to sites and to CRO medical monitor and safety team.
- Coordinate and provide medical training including indication training, protocol training, safety presentations as needed for CRO clinical staff, project teams, or during investigator meetings.
- Review and approve protocols, case report forms, informed consent forms and other miscellaneous study documentation.
- Review and approve final study reports.
- Review and approve study related documents and presentations for internal and external use.
- Ensure quality of medical deliverables in accordance with study project plans.
- Represent the medical part of Clinical development as requested in business development activities including general capabilities presentations, bid defenses, medical costing estimates, and change order assumptions.
- Provide input for monthly status reports, departmental activities, and project/performance related issues to the leadership team and board.
- In-depth exposure to clinical trial planning, execution, data analysis and reporting of clinical trial results.
Requirements
- Medical Degree and post-graduate clinical experience within relevant therapeutic area.
- Two years (minimum) industry experience as a Clinical Research Physician or other equivalent experience within research and development.
- Ability and willingness to travel as required, during study start-up phases travel can be extensive.
- Excellent communication skills.
- Excellent presentation skills.
- Fluent in English, both written and spoken.
- Fluent in a Scandinavian language.
Key Competency Requirements
- Solid Clinical study experience as well as study or clinical experience within relevant medical field.
- Critical thinking skills for problem solving.
- Ability to review, interpret, and analyze information to support discussions and decision making.
- Excellent team player, team builder and at times team leader.
- Understanding the levels of responsibility and accountability within different areas of delegation.
- Knowledge of sponsor responsibilities as defined by GCP and adheres to GxP standards.
Start: As soon as possible.
Location: Stockholm.
Employment type: Full-time (100%).
Do you want to experience the positive culture at a fast-growing company? Are you the Study Physician we are looking for? Send us your application!
- Avdelning
- Medicinska & Regulatoriska tjänster
- Platser
- Stockholm
Om Adxto Recruitment & Consulting
Vi är ett nordiskt vård- och konsultföretag som startades 2007 och är sedan dess en registrerad vårdgivare. Vårt mål är att utveckla och leverera innovativa vård- och konsultlösningar som hjälper människor förbättra sin hälsa. Vi gör detta i samarbete med Life Science-sektorn och vårdens aktörer. Adxto består av två affärsområden, Vårdutveckling och Konsult & rekrytering. Med denna kombination av affärsområden kan vi hjälpa Life Science-bolag och vårdaktörer i de nordiska länderna med allt från market access, genom våra sälj- och marknadskonsulter, till patientstöd på vårdmottagningar, sjukhus, alternativt patientens hem med stöd av våra sjuksköterskor och digitala patientstödsplattform.
Study Physician (Medical Responsible)
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