Medical Director, Clinical Science

Sobi•Boston, MA

3h•$190,000 - $270,000•Remote

About The Position

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.

Requirements

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
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.

Nice To Haves

Experience in Critical Care or Immunology is a plus

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.

Benefits

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
A competitive 401(k) match to support your financial future.
Tuition and wellness reimbursements to invest in your personal and professional growth.
A comprehensive medical, dental, and vision package to prioritize your health and well-being.
Additional recognition awards to celebrate your achievements.