Riboscience
Associate Director/Senior Clinical Trials Manager
Riboscience, San Francisco, California, United States, 94199
COMPANY DESCRIPTION
Riboscience is a clinical stage biotechnology company developing treatments for serious infectious diseases and cancer. We apply ribose and structure-guided design technologies to the discovery of drugs that target proteins that are essential and unique to specific infectious pathogens, tumor cells or the anti- tumor immune response. We are looking for diverse talent to join our team and share with us the passion and excitement in making highly impactful new medicines available to patients with severe infectious diseases or cancer. Riboscience is headquartered in the San Francisco Bay Area with locations in Sunnyvale and Palo Alto.
OPEN POSITION SUMMARY
Title:
Associate Director/Senior Clinical Trial Manager, Clinical Operations (Full-Time Employment).
Location:San Francisco Bay Area
Role:Riboscience is seeking a passionate, creative, and dedicated individual to join our team as an Associate Director/Sr. Clinical Trial Manager to lead/support the delivery of clinical study(ies), ensuring they are conducted on time, within budget, and of appropriate quality.
Essential Functions and Responsibilities:
Lead, delegate and direct clinical trial management activities on multiple early phase and large global studies.
Overall operational execution from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, writing protocols, informed consent documents and contributing to clinical sections of Investigator Brochures).
Leads cross-functional Study Management Team meetings; facilitates discussions and decision-making across functions.
Responsible for site and vendor feasibility, capabilities assessment, selection, management, and oversight.
Provide quality oversight of site management and monitoring activities.
Manage study finances, negotiate vendor contracts, ensure clarity in contracts and budgets, and oversee vendor performance to contract and agreed budget.
Participate in development of study timelines, ensuring close coordination between the company study team and external parties. Manage trial according to agreed timelines.
Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs.
Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
Contribute to or lead the systems set-up/management including EDC, IRT, Central Laboratories, specialty services (ePRO, eDiary, etc.).ility to work in a fast-paced start-up environment with demonstrated capacity to juggle multiple competing tasks and demands.
Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.
Effectively track and communicate program/study progress to Portfolio/Program Directors and Senior Management with ability to create and update detailed dashboards and trackers.
Oversee the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and ensures trial activities are conducted in accordance with agreed plans.
Maintains strong relationships with CROs, vendors, and investigative sites.
Work in partnership with key internal functions including Clinical Development.
Contribute/lead ongoing initiatives within the Clinical Operations, including process improvements and SOP development.
Ability to foster and encourage teamwork, cooperation, and flexibility to get the work done.
Works well in a matrix setting with minimum supervision and self-driven to contribute.
Ability to manage multiple priorities within various clinical trials and to multi-task in a fast-paced start-up environment.
The Ideal Candidate will have:
Bachelor’s degree in scientific discipline required, master’s degree or higher preferred.
At least 10 years’ experience in clinical operations in biotech / pharmaceutical companies.
Experience managing Phase 1-3 multinational/global clinical trials, including successful management of cross-functional teams
Experience with vendor and site selection, contracts and budgeting, and vendor and site oversight
Thorough knowledge and understanding of Code of Federal Regulations (CFR) and Good Clinical Practice/International Council for Harmonization (GCP/ICH) requirements as well as general knowledge and awareness of global regulatory requirements.
Working knowledge of data management, regulatory operations, and pharmacovigilance.
Willingness to be an individual contributor or hands-on team leader, according to project demands.
Experience managing oncology clinical trials strongly preferred.
Strong communication skills (verbal and written).
Excellent organizational and interpersonal skills.
Ability to reason independently and recommend specific solutions in clinical settings.
Proficiency in Microsoft Office (Word, Excel, Outlook, and Project), electronic TMF, and electronic clinical technologies.
Riboscience considers a variety of factors when determining base compensation (or contract rate for contract candidates), including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental and vision insurance plans.
How to ApplyPlease send a cover letter and a copy of your CV to careers@riboscience.com
#J-18808-Ljbffr
Riboscience is a clinical stage biotechnology company developing treatments for serious infectious diseases and cancer. We apply ribose and structure-guided design technologies to the discovery of drugs that target proteins that are essential and unique to specific infectious pathogens, tumor cells or the anti- tumor immune response. We are looking for diverse talent to join our team and share with us the passion and excitement in making highly impactful new medicines available to patients with severe infectious diseases or cancer. Riboscience is headquartered in the San Francisco Bay Area with locations in Sunnyvale and Palo Alto.
OPEN POSITION SUMMARY
Title:
Associate Director/Senior Clinical Trial Manager, Clinical Operations (Full-Time Employment).
Location:San Francisco Bay Area
Role:Riboscience is seeking a passionate, creative, and dedicated individual to join our team as an Associate Director/Sr. Clinical Trial Manager to lead/support the delivery of clinical study(ies), ensuring they are conducted on time, within budget, and of appropriate quality.
Essential Functions and Responsibilities:
Lead, delegate and direct clinical trial management activities on multiple early phase and large global studies.
Overall operational execution from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, writing protocols, informed consent documents and contributing to clinical sections of Investigator Brochures).
Leads cross-functional Study Management Team meetings; facilitates discussions and decision-making across functions.
Responsible for site and vendor feasibility, capabilities assessment, selection, management, and oversight.
Provide quality oversight of site management and monitoring activities.
Manage study finances, negotiate vendor contracts, ensure clarity in contracts and budgets, and oversee vendor performance to contract and agreed budget.
Participate in development of study timelines, ensuring close coordination between the company study team and external parties. Manage trial according to agreed timelines.
Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs.
Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
Contribute to or lead the systems set-up/management including EDC, IRT, Central Laboratories, specialty services (ePRO, eDiary, etc.).ility to work in a fast-paced start-up environment with demonstrated capacity to juggle multiple competing tasks and demands.
Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.
Effectively track and communicate program/study progress to Portfolio/Program Directors and Senior Management with ability to create and update detailed dashboards and trackers.
Oversee the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and ensures trial activities are conducted in accordance with agreed plans.
Maintains strong relationships with CROs, vendors, and investigative sites.
Work in partnership with key internal functions including Clinical Development.
Contribute/lead ongoing initiatives within the Clinical Operations, including process improvements and SOP development.
Ability to foster and encourage teamwork, cooperation, and flexibility to get the work done.
Works well in a matrix setting with minimum supervision and self-driven to contribute.
Ability to manage multiple priorities within various clinical trials and to multi-task in a fast-paced start-up environment.
The Ideal Candidate will have:
Bachelor’s degree in scientific discipline required, master’s degree or higher preferred.
At least 10 years’ experience in clinical operations in biotech / pharmaceutical companies.
Experience managing Phase 1-3 multinational/global clinical trials, including successful management of cross-functional teams
Experience with vendor and site selection, contracts and budgeting, and vendor and site oversight
Thorough knowledge and understanding of Code of Federal Regulations (CFR) and Good Clinical Practice/International Council for Harmonization (GCP/ICH) requirements as well as general knowledge and awareness of global regulatory requirements.
Working knowledge of data management, regulatory operations, and pharmacovigilance.
Willingness to be an individual contributor or hands-on team leader, according to project demands.
Experience managing oncology clinical trials strongly preferred.
Strong communication skills (verbal and written).
Excellent organizational and interpersonal skills.
Ability to reason independently and recommend specific solutions in clinical settings.
Proficiency in Microsoft Office (Word, Excel, Outlook, and Project), electronic TMF, and electronic clinical technologies.
Riboscience considers a variety of factors when determining base compensation (or contract rate for contract candidates), including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental and vision insurance plans.
How to ApplyPlease send a cover letter and a copy of your CV to careers@riboscience.com
#J-18808-Ljbffr