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

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.  Previous experience working on and monitoring clinical trials is required, experience working on regulatory submission documents preferred, and prior experience in Immunology is a plus.

Remote – US Eastern Time Zone, Boston area or Raleigh-Durham area 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 to 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.
• To be successful in these activities, the Medical Director, Clinical Science will possess and continue to develop significant level of knowledge in assigned therapeutic area. Will develop productive relationships and contributions within the cross-functional headquarter team, as well as with local affiliate offices, and collaborative partners. Will role model the highest scientific and ethical standards, and work in accordance with applicable rules and regulations with regards to scientific and medical activities.

• 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
• Therapeutic and/or clinical trial experience with sirolimus and uricase enzymes preferred
• Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making
• 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
• Good organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operations
• Good team-player with high personal and scientific integrity
• Comfortable working in fast paced environment
• Able to demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.
• Demonstrated lateral leadership in a fast paced, agile highly competitive therapeutic environment, with strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict resolution skills.
• Ability to work effectively in a matrix, cross-functional setting; excellent collaboration skills; and experience working with co-development/co-commercialization industry partners would be beneficial
• Able to work well in a virtual environment. Proven self-management by showing initiative, good organization and willingness to be held accountable.
• Ability to work independently with high level of self-motivation at the same time be a team player and have cross-cultural literacy.

The base salary pay range for this role is $190,000-270,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.