Director, Clinical Operations

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
• Current knowledge of Good Clinical Practices, ICH Guidelines, and FDA regulations and the application of the conduct to clinical studies
• 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 position at commencement of employment is expected to be between $210,000 and $245,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together for patients

• Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’sBenefits Portal.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.