Director Clinical Operations

Skills Alliance; New York (NY); Remote; USD 120,000 - 180,000; Full time

Job summary

A leading company in the biotech field is looking for a remote Director of Clinical Operations to lead critical clinical trials focusing on cell therapy programs. You will manage all phases of trials, ensuring quality, adherence to budgets, and timelines. Ideal candidates are seasoned professionals with extensive experience in clinical operations across diverse teams and settings.

Qualifications

• 8+ years in clinical operations, ideally in biopharmaceuticals.
• Experience from Phase 1 to pivotal clinical studies.
• Knowledge of FDA regulations and clinical trial execution principles.

Responsibilities

• Oversee operational aspects of clinical trials.
• Manage study start-up, enrollment, and close-out.
• Develop relationships with partners and valuable contributors.

Skills

Clinical research operations

Cross-functional team management

Budget management

Creativity in problem-solving

Interpersonal communication

Education

Bachelor's in Life Science or Business

Job description

We are seeking a REMOTE Director of Clinical Operations for a 1-year contract role to lead the execution of early- to late-phase clinical trials supporting our Biotech client's cell therapy programs. This is a high-impact position ideal for a seasoned clinical operations leader with deep expertise in managing cross-functional teams, CROs, and vendors in a fast-paced, innovative environment.

About the role

As a Director-level contractor, Clinical Operations, you will be an essential member of the Development team, reporting to the Executive Director, Clinical Scientist. You will support 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
• 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)
• 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 (or combination of clinical operations and clinical development) in the biopharmaceutical industry; clinical development experience a plus
• 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 travel as required

What will separate you from the crowd

• 2+ years of experience in clinical program management
• Specific experience in CAR T trials
• Clinical Development experience