Director, Clinical Operations
1 week ago
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
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's Benefits 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.
-
Director, Clinical Operations
7 days ago
Cambridge, Massachusetts, United States Vor Biopharma Inc. Full timeWho we are looking for:Vor Bio is seeking a highly motivated Director, Clinical Operations to join our fast-paced, dynamic team at this exciting phase of our Clinical Development Program.Key areas of responsibility: Executes the day-to-day operations of clinical trials from the protocol concept through the clinical study report, per established goals and...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Oncology Therapeutic Area. This may include more than one study. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Oncology Therapeutic Area. This may include more than one study. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related...
-
Sr. Director, Clinical Operations, Therapeutics
3 weeks ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Senior Director, Clinical Operations to manage therapeutics programs across the Therapeutics portfolio with a focus on Rare Diseases. The Senior Director, Clinical Operations, Therapeutics will function as a portfolio lead with oversight of programs and the clinical operations team(s) on those programs. This position will work...
-
Sr. Director, Clinical Operations, Therapeutics
1 month ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Senior Director, Clinical Operations to manage therapeutics programs across the Therapeutics portfolio with a focus on Rare Diseases. The Senior Director, Clinical Operations, Therapeutics will function as a portfolio lead with oversight of programs and the clinical operations team(s) on those programs. This position will work...
-
Director, Clinical Biomarkers
1 month ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Modernas Sr. Director of Infectious Disease, Clinical...
-
Director, Clinical Biomarkers
3 weeks ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Modernas Sr. Director of Infectious Disease, Clinical...
-
Cambridge, Massachusetts, United States LEAP THERAPEUTICS, INC. Full timeAssociate Director/Director, Clinical Program ManagementShare to LinkedIn Apply Now Apply NowCompany Summary:Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed...
-
Director, Clinical Biomarkers
7 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Moderna's Sr. Director of Infectious Disease, Clinical...
-
Senior Director, Clinical Research
20 hours ago
Cambridge, Massachusetts, United States Pfizer Full timeJob Description ROLE SUMMARY The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism (POM), proof of clinical activity ( SoCA ) and proof of concept (PoC) and dose ranging studies for novel biological and small molecule therapies in Immunology, Inflammation and ...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology is a pivotal role within the Clinical Operations Therapeutics and Oncology organization. tasked with the oversight of external resources dedicated to co-monitoring activities and site visitations globally, aligned to the larger overarching RBQM/Monitoring...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology is a pivotal role within the Clinical Operations Therapeutics and Oncology organization. tasked with the oversight of external resources dedicated to co-monitoring activities and site visitations globally, aligned to the larger overarching RBQM/Monitoring...
-
Senior Director of Clinical Affairs
20 hours ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleSenior Director of Clinical AffairsJob DescriptionSenior Director of Clinical Affairs Delivers clinical knowledge, experience and expertise across the whole value chain from ideation to end-of-life. Focus in ensuring insights on scientific trends, practices and ethics are embedded in the relevant Philips processes, as well as using insights for...
-
Associate Director, Clinical Pharmacology
1 week ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full timeCompany Description Bicycle Therapeutics (NASDAQ:BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high...
-
Cambridge, Massachusetts, United States Affinity Full timeGlobal Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (possible meetings and functions each quarter in Waltham, MA office) The AD, Monitoring Oversight is responsible for Oversight and implementing a global sponsor oversight monitoring program within the clinical operations department. This...
-
Cambridge, Massachusetts, United States Moderna Full timeThe Role:The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director,...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director, Clinical Operations and is accountable to the Clinical Operations...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director,...
