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Medical Director Clinical Science
2 months ago
Sobi is seeking a highly skilled Medical Director Clinical Science to join our team in the development of innovative therapies for rare diseases. As a key member of our clinical development team, you will be responsible for leading the development of clinical study protocols, reports, and statistical analysis plans, as well as interacting with regulatory authorities and key opinion leaders.
Key Responsibilities- Lead Clinical Development Activities: Provide clinical, scientific, and strategic input to clinical development plans and activities, ensuring the highest scientific and ethical standards are met.
- Medical Director Responsibilities: Act as Medical Director responsible for Sobi-sponsored studies, planning, designing, conducting, and reporting studies in close collaboration with cross-functional teams.
- Collaborate with Cross-Functional Teams: Work closely with Medical Development Lead, Medical Program Lead, and other teams to ensure successful study execution and regulatory submissions.
- Develop Clinical Study Protocols and Reports: Develop high-quality clinical study protocols and reports, contributing to statistical analysis plans and participating in Investigator meetings.
- Interact with Regulatory Authorities: Provide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products/projects.
- Contribute to Regulatory Submissions: Contribute high-quality scientific and medical input to delivery of clinical parts of submissions and responses to Health Authority's questions.
- MD with Clinical Experience: MD with at least 4 years of clinical experience treating patients (rheumatology/immunology preferred) and/or at least 10 years of solid record of accomplishment within rheumatology/immunology drug development programs.
- Therapeutic and Clinical Trial Experience: Therapeutic and/or clinical trial experience with sirolimus and uricase enzymes preferred.
- Expertise in Clinical Development: Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy, and leadership decision-making.
- Communication and Organizational Skills: Good communication skills, capable of representing the company to all audiences, both internally and externally, particularly in the context of collaborations at international conferences and scientific symposia.
- Team Player: Good team-player with high personal and scientific integrity, comfortable working in a fast-paced environment.
Sobi is a global biopharmaceutical company dedicated to rare diseases. We are committed to developing and delivering innovative therapies to improve the lives of people affected by rare diseases. Our team is passionate about making a positive impact, and we are seeking like-minded individuals to join us in this mission.
