Clinical Trial Manager, Clinical Operations
Location: South San Francisco, CA
Blade Therapeutics (“Blade”) is a private biopharmaceutical company founded on a commitment to revolutionize the treatment of debilitating, incurable fibrotic diseases that impact millions of people worldwide. The Company is an expert in novel biological pathways – including autotaxin / lysophosphatidic acid (LPA) and calpain biology – that are foundational to cell and tissue damage responses leading to fibrosis. Blade is advancing a robust pipeline of potential first-in-class investigational therapies for diseases of lung, liver and heart fibrosis, as well as neurodegenerative diseases.
Blade is advancing a robust pipeline of potential first-in-class investigational small-molecule therapies to combat diseases of lung, liver and heart fibrosis, as well as neuro-degenerative conditions. This pipeline includes multiple direct inhibitors of autotaxin / LPA and of dimeric calpains that offer distinct but complementary anti-fibrotic mechanisms.
The Company has assembled critical leadership expertise supplemented by a world-class network of scientific, pharmaceutical and clinical advisors to enable efficient and successful drug development. Since the company’s founding in 2015, Blade has used a combination of in-house drug research and selective in-licensing to build a risk-diversified pipeline. Our focused approach offers tremendous opportunity to produce disease-modifying, life-saving therapies.
Role: Clinical Trial Manager, Clinical Operations (CTM)
The Clinical Trial Manager role will be responsible for the management of the Clinical Operations function in alignment with Blade’s corporate goals and needs of the Development group. With a focus on managerial efficiency and high-quality deliverables, the successful candidate will manage all operational aspects of one or more clinical programs including project planning, budget, resource management, and management of contract research organizations (CROs) and other key vendors.
The successful candidate will be responsible for execution of clinical studies in full compliance with company SOPs, good clinical practices, and applicable regulatory guidelines. The role will take primary responsibility for coordinating with the Vice President of Clinical Operation and other internal stakeholders to ensure appropriate fiscal oversight, including management of vendor scope and change orders. This role will oversee internal and vendor clinical trials staff and manage all aspects of study operations with possible line management duties, and will ensure comprehensive, appropriate escalation of issues to the Vice President of Clinical Operation. The role will function as a cross-functional liaison and create a positive, collaborative team environment with an eye toward innovation and operational excellence.
The Clinical Trial Manager will report to the Vice President of Clinical Operation.
- Contribute to the execution of clinical trials, drive to solutions across a multi-functional study team.
- Anticipate and resolve complex and key technical, operational, or business problems with multi-functional study team; evaluate and determine issues that require escalation.
- Use performance metrics and quality indicators to drive study execution.
- Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study.
- Collaborate with study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
- Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
- Collaborate with vendors and other study team members regarding study specific issues.
- Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
- Plan site and country identification and selection in collaboration with internal partners.
- As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight.
- Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
- Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
- Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
- Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors.
- Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
- Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed.
- Experience with managing clinical research budgets.
- Coordinate with the project team to design both content and format of CRFs, patient documents, reference documents, and forms.
- Mentoring and delegation skills to guide junior team members through monitoring and tracking day-to-day operational deliverables. Desire to provide guidance is a must.
- Review line listings, write and resolve queries, review protocol deviations, and prepare for interim/final Clinical Study Reports.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Experience with managing a multi-functional team, including leadership skills and driving deliverables.
- Demonstrates analytical approach and anticipation of problems.
- Identifies gaps and provides constructive feedback and solutions.
- Follows issues to resolution and escalates as appropriate.
- Ability to multi-task effectively and prioritize assignments from multiple sources.
- Excellent organizational skills.
- Strong communication skills, both written and oral.
- Travel up to 25%.
Required Qualifications and Background
- BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level.
- Pulmonary, or hepatology and or fibrosis experience preferred.
- Experience in managing global clinical trials preferred.
- An attractive compensation package commensurate with this role will be provided.
Interested applicants, please send resume to: Marianne Eid
Blade Therapeutics Is An Equal Opportunity Employer