Scientific Director - iTSB Innovation in Translational Science and Biomarkers

ABOUT CRITICAL PATH INSTITUTE

The Critical Path Institute (CPath) is a global nonprofit organization created to foster development and regulatory endorsement of new design evaluation and metric tools and standards for drug therapy trials to accelerate medical product approval and adoption. CPath acts as a neutral third party to bring together publicprivate partnerships of industry academia and government for precompetitive collaboration and sharing of scientific data. Our continued success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world including our own valued team members.

POSITION OVERVIEW

You will be part of the Type 1 Diabetes (T1D) Consortium at CPath working with project leadership and an interdisciplinary team comprised of: project managers matrix scientists (Data Collaboration Center; Quantitative Medicine Program Regulatory Science Program) and regulatory experts to develop solutions to unmet needs in current and emerging areas of T1D drug development. In addition you may work with crossfunctional teams in areas of common priorities or strategic initiatives.

The individual will work with leadership and consortium members to develop and execute the strategic plan and priorities for T1D Consortium and will be capable of leading both internal and external facing presentations and meetings with CPath governance bodies external opinion leaders and consortium representatives from the biopharmaceutical industry EMA and FDA. The individual is expected to influence the external environment with excellent written communication skills through the coauthoring of drug development tool/novel methodology qualification submission documents publications and regular written updates to consortium stakeholders.

SUPERVISORY RESPONSIBILITIES

N/A.

CORE DUTIES/RESPONSIBILITIES

• Collaborate with T1D consortium Executive Director (ED) to provide scientific oversight of specified project activities.
• Collaborate with ED to lead discussions dealing with regulatory clinical and scientific issues relating to the work of the consortium including data sharing model informed drugdevelopment (MIDD) biomarkers and clinical outcome assessments (COAs).
• Author internal and external communications endorsement documents and scientific publications.
• Foster relationships with key individuals among global regulatory bodies consortium members other research initiatives or other collaborative efforts in the field.
• Develop and guide the of research plans for submissions to regulatory bodies including FDA/EMA in support of MIDD solutions biomarkers COAs etc.
• Collaborate/connect with researchperforming organizations and other publicprivatepartnerships working in the T1D environment.
• Collaborate with other CPath consortia and programs for innovative solutions that may be applied to T1D specific projects.
• Direct project manager(s) for the working groups to provide project implementation/management/oversight/tracking of all collaborative efforts.
• Travel on occasion for outoftown meetings (approximately 10.
• Other duties and responsibilities may be assigned.

REQUIRED KNOWLEDGE SKILLS AND ABILITIES

• Demonstrated knowledge of either immunology or endocrinology is required.
• Knowledge of T1D drug development development of immunerelated medicines cellbased therapies including engineered immune cells and beta cell replacement is strongly preferred but not required.
• Understanding of appropriate FDA and EMA guidelines and how they apply to drug/biologic/device approval drug development tool or novel methodology acceptance is desirable.
• Working knowledge of assay development and validation and biostatistical analysis is desirable.
• Demonstrated ability to work collaboratively think strategically and use an inclusive and consultative approach to problem solving and decision making.
• Demonstrate ability to effectively present data development plans and strategies to various audiences in both verbal and written form; demonstrate ability to author internal and external communication scientific and regulatory documents that are clear and concise.
• Good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of consortia objectives.
• Work independently and lead projects while retaining the ability to operate as a part of a team and take advice and consideration from consortium members.
• Ability to meet target deadlines and manage time effectively balanced across multiple projects.
• Demonstrated aptitude for leading and managing complex teams and deliverables; ability to plan identify contingencies course correct and evaluate project success.

Language Ability:

• Exceptional communication skills in a range of applications: interpersonal relationships formal presentations written electronic communications and scientific and regulatory writing.

Travel Demands: Travel for outoftown meetings (max 10.

REQUIRED KNOWLEDGE SKILLS AND ABILITIES

• PhD (or equivalent doctoral degree) in relevant scientific or clinical discipline.
• 35 years of experience in drug development FDA/EMA and/or translationally focused clinical practice.
• Experience with strategic initiatives and project leadership
• Experience working with regulators in medical product development preferred.

Critical Path Institute is an equal opportunity employer. Visit our website at .