Associate Director, Scientific
Critical Path Institute (C-Path)
- Tucson, AZ
- $106,240-159,360 per year
- Permanent
- Full-time
- Support the ED for CP-RND in development and execution of detailed work plans and associated milestones to generate, evaluate, and prepare applications for submission to the FDA/EMA for qualification of drug development tools.
- Develop and foster positive relationships with all of the consortia's global stakeholders, including biotech/biopharmaceutical organizations, nonprofit research foundations, patient advocacy groups, regulators, and academic/clinician researchers.
- Lead the consortia's data acquisition and database aggregation strategy, including curating a pipeline of high-value datasets to intake and integrate into the consortia's databases.
- Liaise with C-Path's Rare Disease Cures Accelerator - Data and Analytics Platform (RDCA-DAP) program and other internal data and analytics teams (Data Collaboration Center and Quantitative Medicine Programs) and external data contributors.
- Support ED for CP-RND and consortia workgroup co-leads in developing and executing consortia goals and enable progress towards scientific and strategic milestones and timelines while leveraging appropriate course correction, troubleshooting, or risk-mitigation strategies, as applicable.
- Participate in disseminating scientific achievements/advances in peer-reviewed journals and other scientific venues.
- Represent the HD-RSC and CPTA consortia at national and international scientific or regulatory meetings.
- Serve as point of contact for individual consortium members (i.e., workgroup co-chairs, participants, new members) to provide scientific information and coordination with other members of the consortium.
- Support developing strong, positive, professional relationships with regulatory authorities, government agencies, research organizations, patient advocacy groups, etc., (within established policies and compliance standards) and continually look to form relationships and strategic partnerships that will further C-Path's mission.
- Strong critical thinking and analytical skills
- Expertise in managing productivity of complex collaborations and research teams.
- Track best practices and lessons learned and operationalize to develop recommendations for the future.
- Nimbly adapt to shifting priorities and timelines
- 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
- Demonstrated negotiation skills and ability to cultivate and grow external relationships
- Prior experience in evaluating milestones and the context/information provided by external vendors/partners.
- Ability to successfully anticipate issues or challenges and proactively address them without being specifically directed
- Demonstrated experience in medical/scientific writing and earnestness to support the writing and submission from inception to completion, of regulatory submissions and publications in peer reviewed scientific journals.
- Strong publication record
- Scientific track record of success
- Experience in drug development in rare neurodegenerative diseases is preferred.
- Knowledge of good laboratory and clinical practices
- Knowledge of FDA/EMA regulations for clinical development
- Knowledge of data science, working with databases, clinical expertise
- A PhD (or equivalent doctoral degree) in a related scientific or medical discipline and two to four years' experience in drug development (drug discovery, mechanistic pharmacology, clinical development, project management or regulatory affairs in the pharmaceutical industry, at nonprofit research foundations, and/or the FDA).
- Training and professional experience in drug development in neurological disorders.