Vice President of Scientific Affairs

1 week ago

Tucson, Arizona, United States Critical Path Institute (C-Path) Full time
Position Overview

About Critical Path Institute (C-Path)

Critical Path Institute (C-Path) is a nonprofit organization dedicated to enhancing human health by fostering partnerships and innovative methodologies that expedite the development and approval of new therapies. For over a decade, we have collaborated with industry and academic leaders to advance technologies throughout the medical product development continuum, from research to regulatory endorsement. As a prominent nonprofit entity committed to promoting collaboration and data sharing in the precompetitive arena, C-Path has pioneered numerous initiatives aimed at delivering new treatments to patients more swiftly. Our ongoing achievements are supported by a blend of public and private funding from stakeholders who share our mission to accelerate the journey to a healthier world.

Role Responsibilities

The Chief Science Officer (CSO) is tasked with overseeing five key areas related to all scientific initiatives at C-Path:

  • Formulate, refine, and continuously enhance the scientific strategy for C-Path, with guidance from the Executive Team, to develop solutions and resources generated by the organization. This encompasses the management of scientific functions, both in-house and outsourced, including pre-clinical, translational, and clinical research projects, alongside the creation of new processes, technologies, or solutions. This position merges scientific leadership with business acumen to bolster the efficiency, sustainability, and competitive stance of the organization.
  • Envision, develop, and adjust C-Path's core scientific research capabilities (human resources, methodological expertise, and technological needs) in collaboration with the Leadership Team, ensuring the continuous optimization of evidence generation and appropriate regulatory validation of the solutions and resources produced by the organization.
  • Structure C-Path's scientific portfolio to facilitate effective knowledge integration and management across all intersections of the organization's functional matrix.
  • Collaborate with the Executive Team to devise a criteria-based strategy for exploring new business opportunities that align with C-Path's scientific vision, existing competencies, and sustainable growth prospects.
  • Define the scientific components of the organizational strategy to establish innovative revenue streams, including a training revenue strategy for stakeholder scientists on the application of resources and solutions developed by the organization, an adaptive scientific value proposition, and a robust scientific talent management and retention framework.

Supervisory Duties

  • Lead multiple Executive Directors, scientific personnel, and administrative staff across existing and prospective collaborations.
  • Attract, nurture, mentor, and retain high-performing team members, empowering them to expand their responsibilities and enhance their performance.
  • Collaborate with staff to create systems that ensure consistent, high-quality project management.

Core Responsibilities

  • Evaluate C-Path's scientific requirements and propose potential growth and capability enhancement solutions.
  • Design the scientific value chain for generating resources and solutions for medical product development.
  • Assess the scientific benefits of new projects and their alignment with the organizational strategy.
  • Determine both short- and long-term scientific human capital needs for mission-critical initiatives.
  • Plan and supervise the work of diverse scientific expertise lines.
  • Support negotiations with vendors to secure optimal service levels for C-Path's scientific needs.
  • Translate global medical product development realities into the context of C-Path's portfolio of solutions and resources.
  • Provide comprehensive leadership and coordination, as well as administrative and scientific oversight of C-Path's activities.
  • Offer scientific insights into individual projects related to pre-clinical, translational, and clinical issues across various programs and partnerships.
  • Build relationships with key stakeholders in regulatory bodies, industry, advocacy organizations, and academia, as well as foster collaborative research initiatives.
  • Identify, recruit, and qualify new scientific talent for the organization.
  • Engage expert consultants as needed to provide scientific input on projects.
  • Work with C-Path's administration to ensure financial oversight of applicable grants or funds supporting scientific activities.
  • Other responsibilities may be assigned as necessary.

Required Qualifications

  • Experience in designing, conducting, and reporting experiments or studies relevant to regulatory drug development tool submissions.
  • Proven track record in managing a diverse research portfolio.
  • Expertise in data and quantitative sciences, including clinical pharmacology, statistics, epidemiology, experimental design, and emerging methods such as AI and digital health technologies.
  • Experience in managing matrixed teams and resources effectively.
  • Demonstrated ability to lead and manage complex teams and project deliverables.
  • Capability to facilitate scientific activities among diverse stakeholder groups to enhance project execution.
  • Strong vision, ability to find common ground, and provide clear communication to scientific staff amid competing demands.
  • Knowledge of FDA/EMA regulatory pathways and good clinical practices.
  • Strategic planning and leadership capabilities.
  • Effective management, interpersonal, negotiation, and problem-solving skills.
  • Expertise in managing productivity within complex collaborations and teams.
  • Adaptability to shifting priorities, demands, and timelines.
  • Ability to track best practices and operationalize lessons learned within the team.
  • Proactive in identifying improvement opportunities and suggesting constructive changes.
  • Commitment to the highest level of integrity and adherence to C-Path's code of conduct.
  • Proficient in meeting deadlines and managing time efficiently.
  • Strong negotiation skills.
  • Experience in evaluating milestones and contextualizing information provided by vendors.
  • Experience leading a team of researchers.
  • Sound business judgment in decision-making, adhering to internal and external policies and regulations.
  • Strong critical thinking and analytical abilities.
  • Proactive in anticipating issues and addressing them without specific direction.
  • Discretion in handling critical or confidential information.
  • Terminal degree in a relevant discipline related to C-Path's activities.
  • Ten to fifteen years of experience in medical product development and regulatory processes.
  • Comprehensive knowledge of the drug development and regulatory review processes at FDA and EMA.
  • Broad scientific, clinical, technical, and regulatory understanding of the functions involved in medical product development.

Critical Path Institute is an equal opportunity employer. Visit our website for more information.

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