Director, Clinical Operations

4 weeks ago

Cambridge, United States Sana Biotechnology. Full time

**About the role**:
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As **Director, Clinical Operations**, you will be an essential member of the clinical team, reporting to the Sr. Director, Clinical Operations. You will lead clinical operations of Phase 1, first-in-human through pivotal studies for a portfolio of cell and gene therapy programs. You will oversee the overall execution of assigned clinical program(s) with a focus on quality, budget and timelines and you'll oversee strategic partnerships with vendors.

**What you'll do**:

- Oversee all operational aspects of assigned clinical trial(s)
- Manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out
- You must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
- Prepare and/or review study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Product Administration Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Case Report Form (CRFs), CRF Completion Guidelines, and other relevant study plans and charters
- Lead cross-functional study team, as appropriate
- Develop good relationships with all important partners. Contribute at Core Team level beyond operations and able to give input into development strategy
- Provide oversight and guidance if some tasks are delegated to a Clinical Trial Manager or Clinical Trial Assistant
- Participate in study strategy development, data listing reviews, and Clinical Study Report preparation, as appropriate
- Manage the study project plan, including timelines and budget
- Proactively identify potential study issues/risks and recommends/implements solutions
- Oversee and provide training to CRO and clinical vendors, including full service CRO, central lab, imagining, IVRS, and others, but excluding data management vendors
- Manage CRO and vendor work orders and budgets
- Work with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met
- Further manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, trial master file)
- Oversee lab sample reconciliation
- Create and implement corrective action plan when performance expectations are not being met
- Serve as a liaison and resource for investigational sites
- Review site study documents (informed consent template and study tools/worksheets)
- Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
- Contribute to the development of staffing/resourcing plans/mentoring of junior personnel as needed
- Prepare metrics and updates for management, as assigned
- Participate in Inspection Readiness efforts and in preparation for regulatory submissions
- Organize and manage internal study team meetings, investigator meetings and other trial-specific meetings
- Attend cross-functional meetings as needed to represent Clinical Operations and study-specific issues

**What we're looking for**:

- Bachelors (preferably in a Life Science or Business discipline) or equivalent
- 8+ years of experience in a clinical operations role in the biopharmaceutical industry
- Experience in clinical trial processes from Phase 1 through pivotal studies, including principles for accelerated trial execution, including start up, global study management and global regulatory oversight experience
- Track-record of successful clinical trial execution
- Ability to seek out creative solutions for complex problems, manage risk, and to drive compliance with all aspects of study delivery
- An understanding of principles of relationship management across diverse internal and external stakeholders over the course of a clinical development program
- Ability to use data to drive internal discussion and decision making
- Ability to interface with medical personnel at clinical site(s) and also lead multi-disciplinary teams both internally and externally
- Experience managing clinical program budgets
- Excellent interpersonal, verbal and written communication skills are necessary in this collaborative work environment
- Ability to manage direct reports over time

**What will separate you from the crowd**:

- 2+ years of experience in clinical program management
- Specific experience in Neurology, Autoimmune, or CAR T trials
- Experience with building infrastructure for the Clin Ops department, including SOPs, processes, inspection readiness
- Experience managing direct reports

**What you should know**
- Ability to travel as required
- The base pay range for this po

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