We are now looking for a Study Physician to be a part of our cross-functional and knowledgeable team at Cinclus Pharma. As our Study Physician, you will lead the medical work in close collaboration with our CMO, planning and executing the upcoming Phase III studies for our drug candidate, linaprazan glurate. Your initiative and input for decisions are highly valued at Cinclus Pharma, where we are flexible in working toward long-term objectives.
About the position:
You will serve as part of the CMO medical team and lead assigned projects, acting as the sponsor's medically responsible physician for the studies assigned. You will provide medical oversight monitoring for clinical studies, serious adverse event reporting, and tracking. Furthermore, you will communicate safety issues to CROs and vendors, other sponsor representatives, and regulatory authorities.
You will be responsible for providing medical oversight to the screening process, decisions, and medical and laboratory data, as well as medical support and advice to sites and CRO medical monitor and safety team. You will coordinate and provide medical training, including indication training, protocol training, and safety presentations as needed for CRO clinical staff, project teams, or during investigator meetings. You will also review and approve protocols, case report forms, informed consent forms, miscellaneous study documentation, codings, and protocol deviations.
The role also includes coordinating the review and approval of severe adverse event narratives, final study reports, study-related documents, and presentations for internal and external use and ensuring the quality of medical deliverables in accordance with study project plans.
You will 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. It is also included in the role to provide input for monthly status reports, departmental activities, and project/performance-related issues to the leadership team and board.
As identified and requested by CMO, other study-related or medical activities can also be executed, as well as in-depth exposure to clinical trial planning, execution, data analysis, and reporting of clinical trial results.
• Medical Degree and post-graduate clinical experience within a relevant therapeutic area.
• Medical board certification (preferred).
• Ph.D. in relevant field (preferred).
• Two years (minimum) industry experience as a Clinical Research Physician or other equivalent experience within research and development.
• Excellent communication and presentation skills.
• Fluent in English.
• Fluent in a Scandinavian language.
Key Competency Requirements:
• Clinical Research Experience minimum one year.
• Licensed physician.
• Solid Clinical study experience as well as study or clinical experience within the relevant medical field.
• Ability to work autonomously, having a sound judgment and using 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 adhering to GxP standards.
Travel will be necessary for investigator meetings and international congresses and conferences. The frequency and length of the journey will vary depending on the stage of the study program.
Email your application consisting of a CV and personal letter to: email@example.com
Background checks will be performed on the final candidates. Applications are reviewed on a rolling basis.
About Cinclus Pharma
Cinclus Pharma Holding AB (publ) is a clinical stage pharma company developing a small molecule for the treatment of gastric acid related and upper gastrointestinal diseases. Its leading drug candidate linaprazan glurate represents a new class of drugs, Potassium Competitive Acid Blocker (P-CAB), and provides a fast-acting control of intragastric pH by a different mechanism of action than proton-pump inhibitors (PPIs).