ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For over ten years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing 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.

POSITION OVERVIEW

The Chief Science Officer (CSO) is responsible for five main aspects pertaining to all scientific efforts at C-Path:

• Envision, develop and continuously adapt the scientific strategy for C-Path (with the support of the Executive Team), for the development of the solutions and resources generated by the organization. This includes the oversight of the scientific functions of the organization (in-house and outsourced), including pre-clinical, translational and clinical research projects, as well as the development of new processes, technologies or solutions. This role combines scientific leadership and business skills to promote the efficiency, sustainability and competitive position of the organization.
• Envision, develop and adapt (with the support of the Leadership Team) C-Path's core in-house and outsourced scientific research competencies and capabilities (human capital, methodological expertise, and technological requirements), in order to continuously optimize the generation of the necessary evidence and appropriate regulatory endorsement of the validity and utility of the solutions and resources developed by the organization.
• Organize C-Path's scientific portfolio, to generate an efficient knowledge integration and management structure, across all intersections of the structural matrix components of C-Path's functions.
• In partnership with the ET, develop a criteria-based comprehensive strategy for the exploration of novel business opportunities that align with C-Path's scientific strategy, existing core competencies and expertise, as well as opportunities that present sound and sustainable strategic organizational growth.
• With the support of the orthogonal functions, define the scientific aspects of the organizational strategy to establish novel revenue streams. Such lines include, but are not limited to, a revenue strategy for training stakeholder scientists on the use and implementation of resources and solutions developed by the organization, an adaptive scientific value proposition that supports novel revenue streams, as well as the generation of a robust scientific talent management and retention effort.

SUPERVISORY RESPONSIBILITIES

• Direct multiple Executive Directors, scientific staff, and administrative staff for existing and prospective consortia and cross-consortia collaborations.
• Attract, develop, coach, and retain high-performance team members, empowering them to elevate their level of responsibility, span of control, and performance.
• Work with staff to develop systems that ensure consistent, high-quality project management.

CORE DUTIES/RESPONSIBILITIES

• Analyze C-Path's scientific needs and recommend possible growth and infrastructure/capability expansion solutions.
• Design the scientific value chain for the generation of resources and solutions for medical product development.
• Assess the potential scientific gains of new projects, and their alignment with the organizational strategy.
• Determine short- and long-term scientific human capital needs for mission critical efforts.
• Plan and oversee the work of orthogonal scientific expertise lines.
• Support negotiations with vendors to get the highest level of service for C-Path's organization's scientific needs.
• Translate the global medical product development realities into the context of the portfolio of solutions and resources developed by C-Path.
• Provide overall leadership and coordination as well as administrative and scientific oversight of C-Path activities.
• Provide scientific input to individual projects dealing with pre-clinical, translational and clinical issues relating to the work of the specific Programs/Consortia/Non-consortia/consortium-less Public-Private-Partnerships.
• Foster relationships with key individuals among regulatory bodies, industry, advocacy organizations and academic stakeholders, as well research initiatives or other collaborative efforts internally and externally across C-Path.
• Identify, recruit and qualify new scientific talent to the organization.
• Identify and contract with expert consultants, as necessary, to provide scientific input into projects.
• Work with C-Path administration management to provide financial oversight of any applicable grants or funds utilized to support scientific activities in the organization.
• Other duties and responsibilities may be assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Experience with the design, conduct, and reporting of experiments or studies relevant to the preparation of regulatory drug development tool (DDT) submissions.
• Experience in managing a broad research portfolio.
• Experience in data and quantitative sciences, including, but not limited to clinical pharmacology, statistics, epidemiology, experimental design, and novel methods like AI, and digital health technologies.
• Experience in managing matrixed teams and resources.
• Demonstrated aptitude for leading and managing complex teams and project deliverables.
• Ability to facilitate the scientific activities of diverse groups of stakeholders toward improving the conduct of scientific projects.
• Ability to provide vision, find incentives and common ground, and give clear and concise messaging to the scientific staff in the organization, with multiple demands for their time and attention.
• Knowledge of FDA/EMA regulatory pathways.
• Knowledge of good clinical practices.
• Strategic planning and leadership skills.
• Apply effective management, interpersonal, negotiation, and problem-solving skills.
• Expertise in managing productivity of complex collaborations and teams.
• Adapt to shifting priorities, demands, and timelines.
• Track best practices and lessons learned and operationalize those within the team.
• Identify opportunities for improvement and make constructive suggestions for change.
• Practice highest level of integrity and core value system consistent with C-Path's code of conduct.
• Ability to meet target deadlines and manage time effectively.
• Demonstrate negotiation skills.
• Prior experience in evaluating milestones and the context of information being provided by vendors/providers.
• Experience managing a team of researchers.
• Exercise sound business judgment when making decisions and adhere to external and internal policies and regulations.
• Strong critical thinking and analytical skills.
• Ability to successfully anticipate issues or challenges and proactively address without being specifically directed.
• Use sound judgment when working with critical or confidential information.
• Terminal degree in a relevant discipline related to C-Path activities.
• Ten to fifteen years' experience in medical product development and regulatory processes.
• Detailed knowledge of the drug development and regulatory review process at FDA and EMA.
• Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of medical products.

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.

COVID-19

All C-Path employees must vaccinate to safeguard the health of our employees and their families and the community at large from COVID-19.

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. Accommodations 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.