Medical Director, Clinical Science

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

The Medical Director, Clinical Science is responsible for Sobi’s clinical development activities on a product/indication and serves as scientific and medical expert on matters relating to the assigned development program including operational, regulatory and drug safety. 

To be successful in this role, the Medical Director, Clinical Science will possess and continuously develop a high level of expertise in the assigned therapeutic area. The role requires building strong, productive relationships across cross-functional headquarters teams, local affiliate offices, and external collaborative partners. The Medical Director will serve as a role model for the highest scientific and ethical standards, conducting all scientific and medical activities in full compliance with applicable rules and regulations.

This is a remote position - US East Coast candidates are preferred.

Key responsibilities:

• Provide clinical, scientific, and strategic input to clinical development plans and activities, while adhering to the highest scientific and ethical standards ensuring for success.
• Act as Medical Director responsible for Sobi-sponsored studies.
• Responsibility for planning, designing, conducting (including medical monitoring) and reporting Sobi-sponsored studies, in close collaboration with the Medical Development Lead (MDL), Medical Program Lead (MPL) and other core members of the development team, clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.
• Member of the Medical Development Team and of Clinical Study Team(s) and collaborate with the Medical Development Lead for scientific and medical development strategy.
• Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications.
• Responsible for development of clinical study protocols and reports and contribute to the statistical analysis plans, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriate
• Provide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products/projects, as requested and appropriate.
• Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority’s questions to support e.g., briefing documents, scientific advice, BLA/MAA applications.
• Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.

Qualifications

• Medical Degree required
• At least 4 years clinical experience treating patients and/or at least 10 years of solid record of accomplishment within drug development programs demonstrating outstanding and intimate understanding of various phases of clinical trials
• Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making
• Previous experience (>5 years) working on and monitoring clinical trials is required
• Experience working on and supporting regulatory submissions is preferred
• Experience in Critical Care or Immunology is a plus
  
  Personal Attributes:
• Good communication skills, capable of repres