Scientific Director - iTSB

ABOUT CRITICAL PATH INSTITUTE

The Critical Path Institute (C-Path) 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. C-Path acts as a neutral third party to bring together public-private partnerships of industry, academia and government for pre‐competitive 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 C-Path, 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 cross-functional 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 C-Path 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 co-authoring 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 drug-development (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 execution of research plans for submissions to regulatory bodies including FDA/EMA in support of MIDD solutions, biomarkers, COAs, etc.
• Collaborate/connect with research-performing organizations and other public-private-partnerships working in the T1D environment.
• Collaborate with other C-Path 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 out-of-town 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 immune-related medicines, cell-based 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 out-of-town meetings (max 10%).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• PhD (or equivalent doctoral degree) in relevant scientific or clinical discipline.
• 3-5 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 www.c-path.org.

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Reasonable Accommodation:

Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodation will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department.

Salary : $122,160 - $183,240