Job Description
ABOUT CRITICAL PATH INSTITUTE
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 twenty 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.
The Sr. Scientific Director (Sr. SD) for the Critical Path for Parkinson's (CPP) consortium is responsible for the coordination of activities to accelerate research with a focus on sex-differences in Parkinson's. The Sr. SD works with executive leadership and an interdisciplinary team comprised of project managers, clinical scientists, and regulatory experts to evaluate data, identify unmet needs in clinical trials, and support the advancement of aligning drug development efforts with global evidence.
CORE DUTIES/RESPONSIBILITIES
- Collaborates with leadership to provide overall operational, administrative, and scientific oversight of specified project activities.
- Guide the execution of research plans, task lists, milestones, and timelines for supporting grant deliverables and milestones.
- Lead related workgroup teleconferences and meetings to develop and refine research plans, task lists, milestones, and timelines to ensure progress towards the scientific and strategic objectives.
- Oversees CPP and GEM-PD's data acquisition strategy, including curating a pipeline of high-value datasets to intake and integrate into CPP's Integrated Parkinson's Database.
- Provides scientific input to clinical and scientific issues regarding data sharing, data use agreements, disease and medical ontologies, data analysis, and clinical protocol development.
- Provides actionable recommendations based on interpretation of data analyses results with respect to their impact on development of quantitative drug development tools, including implications, opportunities, and limitations.
- Prepares scientific summaries and reports which will be used for regulatory submissions and
- Lead the development of scientific publications to disseminate initiative achievements and advances in peer-reviewed journals and other scientific venues.
- Develop and foster positive relationships with all CPP and GEM-PD global stakeholders, including biopharmaceutical companies, non-profit research and advocacy organizations, regulators, and academic/clinician researchers.
- Continuously evaluate opportunities for additional scientific expertise and funding to ensure sustainability of the GEM initiative across neurological disorders and to expand the impact of PD to PD and related disorders.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Demonstrated experience in medical writing.
- Expertise in managing productivity of complex collaborations and cross-matrix research teams.
- Ability to adapt to quickly shifting and evolving priorities, demands, and timelines.
- Demonstrated ability to effectively present data, development plans and strategies to various audiences in both verbal and written form; demonstrates ability to author internal and external communication, scientific and regulatory documents that are clear and concise.
- Ability to successfully anticipate issues or challenges and proactively address without being specifically directed.
- Demonstrated ability to work collaboratively, think strategically, and use an inclusive and consultative approach to problem solving and decision making.
- Excellent verbal and written communication
- Excellent interpersonal and customer service
- Excellent organizational skills and attention to
- Excellent time management skills with a proven ability to meet
- Experience managing a diverse team with the ability to achieve consensus in multidisciplinary efforts.
- Strong critical thinking and analytical skills.
- Strong analytical and problem-solving
- Practice highest level of integrity and core pillars consistent with C-Path's code of conduct.
- Exercise sound business judgment and adhere to all applicable policies and regulations.
- Ability to prioritize tasks and to delegate them when needed.
- Proficient with Microsoft Office Suite or related
PREFERRED KNOWLEDGE, SKILLS AND ABILIITES
- Experience in clinical research as it applies to drug development across neurological disorders.
- Understanding of policies, regulations, and guidelines related to evaluation of safety and efficacy of medical products for PD and related disorders including dementias.
- Proficiency or experience working with regulators for drug development is an asset.
REQUIRED EDUCATION AND EXPERIENCE
- A PhD (or equivalent doctoral degree) in a scientific or medical discipline.
- Two to five years' experience in drug development (clinical research, drug development tools, biomarkers, mechanistic pharmacology, clinical development, project management, or regulatory affairs).
- 7-10 years of experience in neurological disorders.
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.
Critical Path Institute is an equal opportunity employer. Visit our website at www.c- path.org
Reasonable Accommodation:
C-Path complies with federal and state disability laws and makes reasonable accommodation for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact C-Path HR department at hr@c-path.org
