Vice President of Scientific Innovation
2 weeks ago
Critical Path Institute (C-Path) is a nonprofit organization dedicated to fostering collaborations and innovative methodologies that enhance human health by minimizing the time, expenses, and risks associated with 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 premier nonprofit entity committed to promoting collaboration and data sharing in the precompetitive arena, C-Path has spearheaded numerous initiatives aimed at expediting the delivery of new treatments to patients. Our ongoing achievements are supported by a blend of public and private contributions from stakeholders who share our mission to accelerate the journey toward a healthier world.
POSITION OVERVIEW
The Vice President of Scientific Innovation is accountable for several key responsibilities related to all scientific initiatives at C-Path:
- Formulate, refine, and continuously evolve the scientific vision for C-Path (with input from the Executive Team), focusing on the development of solutions and resources produced by the organization. This encompasses oversight of scientific operations (both internal and external), including preclinical, translational, and clinical research endeavors, as well as the creation of novel processes, technologies, or solutions. This role merges scientific leadership with business acumen to enhance the efficiency, sustainability, and competitive standing of the organization.
- Design, develop, and adapt (with the support of the Leadership Team) C-Path's essential in-house and outsourced scientific research capabilities (human resources, methodological expertise, and technological needs) to continuously optimize the generation of necessary evidence and secure appropriate regulatory validation of the solutions and resources created by the organization.
- Structure C-Path's scientific portfolio to facilitate effective knowledge integration and management across all intersections of the organizational matrix components.
- Collaborate with the Executive Team to devise a criteria-based comprehensive strategy for exploring innovative business opportunities that align with C-Path's scientific vision, existing core competencies, and prospects for sound and sustainable organizational growth.
- With support from auxiliary functions, delineate the scientific components of the organizational strategy to establish new revenue streams, including, but not limited to, a revenue model for training stakeholder scientists on the application and implementation of resources and solutions developed by the organization, an adaptive scientific value proposition that supports novel revenue avenues, and the establishment of a robust scientific talent management and retention strategy.
- Lead multiple Executive Directors, scientific personnel, and administrative staff for current and prospective consortia and cross-consortia collaborations.
- Attract, nurture, mentor, and retain high-performing team members, empowering them to enhance their responsibilities, control, and performance.
- Collaborate with staff to create systems that ensure consistent, high-quality project management.
- Evaluate C-Path's scientific requirements and propose potential growth and infrastructure/capability enhancement solutions.
- Design the scientific value chain for the generation of resources and solutions for medical product development.
- Assess the potential scientific benefits of new projects and their alignment with the organizational strategy.
- Identify short- and long-term scientific human capital needs for mission-critical initiatives.
- Plan and supervise the work of complementary scientific expertise lines.
- Support negotiations with vendors to secure the highest level of service for C-Path's scientific requirements.
- Translate 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.
- Offer scientific insights to individual projects addressing preclinical, translational, and clinical matters related to the work of 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 as research initiatives or other collaborative efforts both internally and externally across C-Path.
- Identify, recruit, and qualify new scientific talent for the organization.
- Identify and contract with expert consultants, as necessary, to provide scientific input into projects.
- Collaborate with C-Path administration management to ensure financial oversight of any applicable grants or funds utilized to support scientific activities within the organization.
- Other duties and responsibilities may be assigned.
- Experience with the design, execution, and reporting of experiments or studies relevant to the preparation of regulatory drug development tool (DDT) submissions.
- Experience in managing a diverse research portfolio.
- Experience in data and quantitative sciences, including, but not limited to, clinical pharmacology, statistics, epidemiology, experimental design, and innovative methods such as AI and digital health technologies.
- Experience in managing matrixed teams and resources.
- Demonstrated ability to lead and manage complex teams and project deliverables.
- Ability to facilitate the scientific activities of diverse stakeholder groups to enhance the execution of scientific projects.
- Ability to provide vision, identify incentives and common ground, and deliver clear and concise messaging to the scientific staff within the organization, amidst multiple demands for their time and attention.
- Knowledge of FDA/EMA regulatory pathways.
- Knowledge of good clinical practices.
- Strategic planning and leadership capabilities.
- Effective management, interpersonal, negotiation, and problem-solving skills.
- Expertise in managing the productivity of complex collaborations and teams.
- Ability to adapt to shifting priorities, demands, and timelines.
- Track best practices and lessons learned and operationalize those within the team.
- Identify opportunities for improvement and provide constructive suggestions for change.
- Exhibit the highest level of integrity and a 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 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 proactively anticipate issues or challenges and address them without specific direction.
- Utilize sound judgment when handling critical or confidential information.
- Terminal degree in a relevant discipline related to C-Path activities.
- Ten to fifteen years of experience in medical product development and regulatory processes.
- Comprehensive 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.
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.
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