The Program Officer is a key member of the Critical Path Institute Executive Team, and works directly with the CEO, COO, CTO, and CSO to develop high-level strategic priority initiatives, execute decisions within the organization, improve the quality of its programs, and achieve operational excellence. The incumbent has responsibility to manage a number of Executive Directors and project teams within a portfolio.
As Program Officer of the Neuroscience Program area, which currently includes consortia working in Alzheimer’s Disease, Parkinson’s Disease, Multiple Sclerosis, Duchenne Muscular Dystrophy, and Huntington’s Disease, this position will develop new projects, provide operational excellence, financial oversight, project implementation management, as well as collaborate and share findings with others across the organization. The Program Officer is responsible for the strategic planning, management, and activities of collaborative research endeavors with various stakeholders with a focus on scientific innovation and advancing regulatory science. The Program Officer communicates the vision of various programs and initiatives to key stakeholders, including pharma, academia, and government participants; existing and potential funders; strategic partners, and the scientific community through talks and scientific publications.
As a key member of the C-Path Executive Team, provide input to and share ownership of high-level, long-range strategic development planning and goal development for C-Path.
Together with Executive Directors, actively contribute to all C-Path leadership activities in the management of consortia and other programs.
Function as a collaborative and collegial member of the C-Path Leadership Team to report progress, share information in real time, and evaluate strategic initiatives from a business and advocacy perspective. Ensure that Executive Directors and other scientific staff reporting to the Program Officer also function as collaborative and collegial members of the team.
Implement new business development opportunities following C-Path’s framework for new business development, including the development of work scopes, funding budgets, and legal structures for consortium start-up, as well as staffing plans. Oversight of new business development opportunities within Program areas ensuring continuity of process and adherence to C-Path’s goals and policies.
Proactively engage in problem solving and conflict resolution within and among teams.
Cross Consortia Development/Collaboration
Maintain knowledge of and commitment to the mission of C-Path and its various consortia.
In collaboration with other C-Path Program Officers and members of the Executive Team, identify new ideas and initiate actions that will positively influence all consortia. Maintain mindset of monitoring program developments and evaluating broader impact across C-Path. Communicate effectively across the organization on these relevant matters. Focus across the organization to improve C-Path’s outcomes and reputation.
Work collaboratively with others to identify, clarify, and develop business strengths and opportunities. Contribute to mechanisms to objectively evaluate all programs against current success and future potential, including the desirability and/or necessity of continuing or ceasing such programs and services.
Coordinate vertically and horizontally with Executive Directors to develop operational cross-functional efficiency and maintain fiscal controls across consortia within area of responsibility.
Provide support to Executive Directors in their responsibility for financial oversight of any grants or funds utilized to execute the work of the consortia and initiatives within area of responsibility.
Provide scientific input to program/consortia discussions dealing with preclinical and clinical science issues.
Contribute to strengthening and standardizing, where appropriate, C-Path’s roles, processes, and tools for carrying out its mission, taking advantage of industry and scientific research best practices.
Collaborate and serve as a key liaison with external strategic partners.
Collaborate with the COO, CTO, and CSO in the appropriate integration of all shared services within the matrix organization.
Department Leadership and Operations Management
Provide overall leadership and administrative and scientific oversight of activities within the Neuroscience Program.
Direct multiple Executive Directors, scientific staff, project managers, project coordinators, and work groups for existing and prospective consortia and programs to ensure effective operation including project implementation, management, oversight, and tracking of all collaborative efforts within consortia and other workgroups and governing bodies.
Working with human resources, participate in the career development and continual learning of direct reports. Develop and maintain a “recruitment mindset” as it relates to understanding and utilizing best practices to attract, engage, and retain top talent.
In collaboration with the COO and other Program Officers, prepare annual department budget(s), manage expenditures, and report business/financial challenges and solutions to the CEO.
Provide leadership, guidance, and oversight to the consortia and project teams’ execution of detailed work plans and milestones to develop, evaluate, and prepare applications for submission to the FDA/EMA or PMDA for qualification of biomarkers, clinical outcome assessment measures, in vitro models, quantitative disease models, etc., for a specific use in drug development as appropriate.
In collaboration with Executive Directors, recruit and qualify new organizations from pharmaceutical, biotechnology, and device companies for potential membership in the consortia or initiatives; enlist other research-performing organizations that are doing work in the area to participate and share their expertise and data.
Ensure optimal scientific and regulatory strategies are in place for each consortium.
Ensure the creation and execution of detailed research work plans for each consortium/project and revise as appropriate to meet changing needs and requirements.
Lead, when necessary, teleconferences and meetings to ensure progress towards scientific and strategic objectives of the Team.
In collaboration with Executive Directors, identify and contract with expert consultants, as necessary, to provide scientific input into projects.
Other duties and responsibilities as assigned.
Scientific Community Representation
Establish and actively lead collaborations with other organizations relevant to C-Path’s work.
Support developing strong, positive, professional relationships with regulatory authorities, government agencies, research organizations, Foundations, NGOs, etc., (within established policies and compliance standards) and continually look to form relationships and strategic partnerships that will further C-Path’s mission.
Ensure the communication of consortia and initiative progress via scientific publications and presentations.
Serve as representative of C-Path in various settings as requested by CEO.
Seven to ten years’ experience in drug development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, project management, or regulatory affairs in the pharmaceutical industry and/or FDA/EMA).
Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of pharmaceutical products.
Ability to operate and provide leadership within a matrix organization structure with interdisciplinary cross-functional teams.
Strong experience in cross-functional communication and decision-making, and ensuring alignment with internal and external stakeholders.
Demonstrated commitment to organizational, professional, and scientific learning and development.
Strong inter-personal and team process skills, problem-solving skills including collaborative negotiation and conflict resolution.
Familiarity with the design, conduct, and reporting of experiments or studies relevant to the preparation of IND applications: for example, the applications of novel efficacy or safety biomarkers, or preclinical efficacy models.
Working knowledge of assay development and validation, and biostatistical analysis.
Working knowledge of regulatory approval and the drug development process.
Demonstrated aptitude for leading and managing complex teams and deliverables.
Ability to provide vision, find incentives and common ground, and give clear and concise messaging to consortium of scientists with multiple demands for their time and attention.
Knowledge of FDA/EMA/PMDA regulations and requirements.
Working knowledge of good clinical practices.
Track best practices, lessons learned, and opportunities for improvement, and operationalize those within the team.
Nestled in the foothills of the Catalina mountains in Tucson, is a nonprofit engaged in world-changing work every day. Critical Path Institute is an independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona (SFAZ), and the U.S. Food and Drug Administration (FDA). C-Path is committed to improving he...alth and saving lives by accelerating the development of safe, effective medicines. An international leader in forming collaborations around this mission, C-Path has established global partnerships that currently include over 1,000 scientists from government regulatory agencies, academia, patient advocacy organizations, and 36 major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona.