ABOUT CRITICAL PATH INSTITUTE (C-PATH)

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 over ten 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.

POSITION OVERVIEW

The Associate Scientific Director (ASD) for the Duchenne Regulatory Science Consortium (D-RSC) will work with leadership and interdisciplinary and cross functional teams comprised of project managers, clinical, data and quantitative medicine scientists, and regulatory experts, to advance novel drug development tools to address unmet medical needs for Duchenne muscular dystrophy and other dystrophinopathies.

The ideal candidate will work with project leadership to develop, define, and execute priorities of key consortium activities including several modeling projects of biomarkers and outcome measures, all at different stages in development and regulatory review. The ASD will be capable to serve as a facilitator and lead for both internal and external facing presentations and meetings with C-Path governance bodies, key opinion leaders and representatives from different stakeholder groups to evolve the strategy and implementation of D-RSC's mission and goals, translating scientific advances into drug development solutions as efficiently as possible.

CORE DUTIES/RESPONSIBILITIES

• Support the Executive Director for D-RSC in development and execution of detailed work plans and associated milestones to prepare applications for submission to the FDA/EMA for qualification of drug development tools.
• Lead D-RSC data acquisition and database aggregation strategy, including curating a pipeline of high-value datasets to intake and integrate into D-RSC databases.
• Liaise with C-Path's Rare Disease Cures Accelerator - Data and Analytics Platform (RDCA-DAP) program and other internal data management and analytics teams (Data Collaboration Center and Quantitative Medicine Programs) and external data contributors.
• Support D-RSC workgroup activities focused on quantitative methodologies, dystrophin related cardiomyopathy, biomarkers, and Clinical Outcome Assessment (COA) development, developing and executing consortia goals that enable progress towards scientific and strategic milestones and timelines.
• 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.
• Lead development and author scientific publications to disseminate consortium achievements/advances in peer-reviewed journals and other scientific venues.
• Represent D-RSC and C-Path at national and international scientific conferences or regulatory meetings.
• Develop and foster positive relationships with all D-RSC global stakeholders, including biotech/biopharmaceutical organizations, nonprofit research foundations, patient advocacy groups, regulators, and academic/clinician researchers.
• Continually look to form new and existing relationships/strategic partnerships that will further C-Path's and D-RSC's mission.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Ability to work collaboratively, think strategically, and use an inclusive and consultative approach to problem solving and decision making.
• 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.
• Knowledge of trial design, protocol development and regulatory requirements to test and evaluate hypothesis generated using real-world data and randomized clinical trial data.
• Understanding of challenges to and opportunities currently presented in drug development for rare neuromuscular dystrophies based on drug development pipeline, pre-clinical and translational research.
• Ability to define data-driven milestones and deliverables and assess which outcome measure and clinically significant endpoints need to be pursued in future data negotiation for database implementation strategy.
• Demonstrated negotiation skills and ability to cultivate and grow external relationships
• Nimbly adapt to shifting priorities and timelines.
• Strong critical thinking and analytical skills
• Expertise in managing productivity of complex collaborations and research teams

Essential Prerequisites:

• Strong publication record
• Scientific track record of success

Preferred Skills/Experience:

• Experience in drug development in rare neuromuscular disorders 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.

REQUIRED EDUCATION AND EXPERIENCE

• 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 regulatory science).
• Training and professional experience in drug development in neurological disorders.

Critical Path Institute is an equal opportunity employer. Visit our website at www.c-path.org

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.

COVID-19

All C-Path employees must vaccinate to safeguard the health of our employees and their families and the community at large from COVID-19.

REASONABLE ACCOMMODATION:

Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department.