Clinical Research Scientist Jobs

Target ALS is a 501(c)(3) public non-profit whose mission is to accelerate ALS research into successful clinical trials. Since 2013, the foundation has built an innovative ecosystem for biomedical research that has catalyzed ALS drug discovery through collaborations.

The foundation is now going through a period of exponential growth with over $200M already raised as part of a $250M capital campaign, building on its successful model that will ensure that it plays a major role in the achievement of its goal, a world where everyone with ALS lives.

Reporting to the Sr. Director of Scientific Programs, the Clinical Research Scientist will help implement strategy for maintenance and expansion of Target ALS biosample and dataset core facilities as well as clinical trial associated activities. The Clinical Research Scientist will provide leadership and work directly with PI and managers of core facilities to execute on goals for Target ALS Natural History Study, Longitudinal Biofluid Repository, Post-mortem Tissue Repository, Genomic and other -omic dataset Cores (Core Facilities).The position will be remote (based within USA) with 15% travel.

The successful candidate will:

• Provide expert guidance and oversight of clinical research activities across US-based and several international Target ALS core sites.
• Manage the biosample and dataset request approval system for Target ALS Cores.
• Manage Target ALS diversity initiative aimed at increasing participation of rural, under-represented and minority communities in ALS research.
• Collaborate with the Grant funded Biofluid and Post-mortem core facility investigators to manage and drive growth of these core resources.

Job Responsibilities:

• Manage creation of complex sample management plans to ensure proper collection and storage of samples for analysis.
• Provide annual updates to the ClinicalTrials.gov website.
• Drive development of study design and research plans for clinical studies
• Lead on-boarding and training of new biofluid and postmortem tissue core sites.
• Participate in writing study protocols, ICFs, and other study documents;facilitate timely protocol revisions.
• Provide guidance to core facility program managers.
• Troubleshoot challenges that arise in implementing clinical studies.
• Ensure utilization of NIH Common Data Elements into the data management scheme
• Ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice.
• Oversee LIMS system in coordination with core programmanager. Collaborate with sites to streamline and codify data entry for LIMS system.
• Provide guidance to Target ALS coordinators at individual sites.
• Collaborate with bioinformatician to perform data analysis for clinical study endpoints
• Manage the Foundation’s grant funded biofluid core, postmortem and dataset core facility programs.
• Create systems and tools to manage sample analysis and facilitate biomarker vendor interactions.
• Work with regulatory personnel to ensure compliance on all aspects of clinical research

·Provide expert advice on non-competitive grants and TALS growth initiatives related to clinical research and patient outreach.

• Interface with key medical experts and represent Target ALS at conferences.
• Provide regular updates to Target ALS leadership on core facility activities.

Qualifications and Skills

• Experience in Neurodegenerative disease is preferred.
• Proven track record in supporting regulatory engagements with a preference for early-stage clinical study experience.
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
• Excellent communication skills (oral and written) and excellent organizational skills.
• Demonstrated strategic and critical thinking.
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment and influence within a matrix.
• Act as subject-matter expert on high-dimensional biomarker technologies including genomic and proteomic technologies.
• M.D. or Ph.D. preferred. Candidates with advanced degrees in science (PharmD and clinical pharmacologists) with appropriate experience will also be considered.
• At least 3 years’ experience in clinical trial operations and translational research in academia or pharma/biotech industry.

Compensation

·Salary is competitive and commensurate with background and experience. The salary range is $140,000-$195,000. The Foundation offers a complete benefit package including Health, Dental, Vision, FSA, 403b retirement program, various insurance coverages.