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Clinical Science Medical Lead
3 months ago
The Director of Clinical Science is tasked with overseeing Sobi's clinical development initiatives for the SEL-212 and Doptelet products. This role serves as the primary scientific and medical authority regarding the designated development program, addressing operational, regulatory, and safety concerns.
Core Responsibilities
- Deliver clinical, scientific, and strategic insights to clinical development strategies and activities, ensuring adherence to the highest ethical and scientific standards for optimal outcomes.
- Function as the Medical Director for Sobi-sponsored clinical trials.
- Oversee the planning, design, execution (including medical oversight), and reporting of Sobi-sponsored clinical trials, collaborating closely with the Medical Development Lead, Medical Program Lead, and other cross-functional teams.
- Participate as a member of the Medical Development Team and Clinical Study Teams, working alongside the Medical Development Lead to formulate scientific and medical strategies.
- Engage with key opinion leaders and lead advisory boards to shape the development roadmap for new products and indications.
- Accountable for the creation of clinical study protocols and reports, contributing to statistical analysis plans, and participating in Investigator meetings and other study-related tasks.
- Provide strategic and operational clinical development expertise in interactions with regulatory bodies for assigned projects.
- Contribute high-quality scientific and medical input to clinical sections of submissions and regulatory documents, as well as responses to inquiries from Health Authorities.
- When applicable, offer scientific and medical support to other Sobi functions in specific therapeutic areas, including global safety and medical affairs activities.
- To excel in this role, the Director of Clinical Science must cultivate a deep understanding of the assigned therapeutic area, fostering productive relationships within the cross-functional headquarters team and with local affiliates.
Qualifications
- MD with a minimum of 4 years of clinical experience in patient care (preferably in rheumatology/immunology) or at least 10 years of demonstrated success in rheumatology/immunology drug development.
- Experience with sirolimus and uricase enzymes is preferred.
- Ability to integrate medical and scientific insights into business development and corporate strategy.
- Strong communication skills, capable of representing the organization to diverse audiences, particularly in international collaborations.
- Excellent organizational skills and a proactive approach to project management.
- A collaborative team player with high personal and scientific integrity.
- Comfortable in a dynamic, fast-paced environment.
- Exhibit behaviors aligned with Sobi's core values: Care, Ambition, Urgency, Ownership, and Partnership.
- Demonstrated leadership in a competitive therapeutic landscape, with strong interpersonal skills including negotiation and conflict resolution.
- Ability to work effectively in a matrixed, cross-functional environment; experience with co-development partners is advantageous.
- Proven self-management skills, with the ability to work independently while being a supportive team member.
- Cross-cultural literacy and the ability to adapt to a virtual working environment.
Company Culture
At Sobi, we are committed to challenging the status quo. Our focus on rare diseases drives our mission to develop innovative solutions that improve patient outcomes. We believe in the power of collaboration and partnership to create meaningful change in the lives of those affected by rare diseases.
Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications.
