As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with T1D better while driving toward cures. We invest in the most promising research to turn ideas into life-changing therapies and devices. We work with government, regulatory officials, and insurance companies to address issues that impact the T1D community - breaking through barriers that limit access to care worldwide. We provide resources and guidance that makes it easier to live and thrive with T1D. This is more than a moment - we're empowering a movement for the T1D community. Share your support and help educate and empower individuals facing type 1 diabetes.
Our missing is to improve lives today and tomorrow by accelerating life changing breakthroughs to treat, prevent and ultimately, cure T1D and its complications. Always, we are guided by a single purpose: As we drive towards curing type 1 diabetes, we help make everyday life better for the people who face it.
BROAD FUNCTION AND SCOPE OF THE POSITION:
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Lead and develop Breakthrough T1D strategy to accelerate regulatory approval of drugs, biologics and medical devices for priority type 1 diabetes therapies.
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Collaborate with Senior Director, Regulatory Affairs on strategies to advance priority drugs, biologics and/or medical devices.
SPECIFIC RESPONSIBILITIES:
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Develop and implement Breakthrough T1D strategies to accelerate regulatory approval for priority drugs, biologics, and medical devices such as beta cell replacement therapies, disease modifying immune therapies, and therapies to improve glucose control and complications associated with type 1 diabetes.
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Manage planning and engagement with industry partners regarding regulatory processes.
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Provide strategic assessment and support for Breakthrough T1D funded academic investigators to ensure success for regulatory submission to conduct research studies.
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Interface directly with regulators as needed.
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Identify needs for outside regulatory advisors and oversee work.
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Assess legislative and regulatory policy proposals and collaborate with internal and external stakeholders to communicate impacts to Breakthrough T1D's mission and develop strategies to mitigate risks and advance priorities.
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Collaborate closely with members of the Breakthrough T1D scientific, advocacy and communications teams.
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Report on progress and advise Breakthrough T1D leadership and allies on regulatory issues as needed.
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Perform other duties as assigned by immediate supervisor.
YEARS OF EXPERIENCE:
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5-10 years of related experience
KNOWLEDGE:
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Extensive knowledge of FDA drug/biologics and/or medical device regulatory guidance, processes, policy, and officials.
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Knowledge of diabetes-related therapies helpful but not necessary.
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Proficiency in Microsoft Office.
OTHER REQUIREMENTS:
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Experience with developing, implementing, and leading product specific regulatory interactions with US FDA and/or other regulatory bodies for early and/or late clinical stage development programs OR experience developing, implementing, and leading regulatory policy initiatives.
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Proven track record of success in achieving approvals for complicated medical therapies desired.
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Self-starter that requires little supervision and can work and make judgments independently.
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Can effectively multi-task, establish priorities, and work in a fast-paced environment.
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Excellent written, oral, and communication skills.
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Travel (approximately 10%).
EDUCATION:
Advanced scientific or legal degree preferred.
Target Salary: $130-170k
Essential Functions:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools or controls. The employee is occasionally required to stand, walk, sit, reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl.
The employee must occasionally lift and/or move up to 25 pounds, and infrequently up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.
The noise level in the work environment is usually moderate.
Additional information:
Requests for medical, religious, and other exemptions will be considered on an individual basis. Breakthrough T1D will comply with all federal, state, and local laws.
Breakthrough T1D supports a diverse and inclusive workforce.
Breakthrough T1D is an Equal Opportunity Employer.
All your information will be kept confidential according to EEO guidelines.