Clinical Operations Senior Manager

A2 Biotherapeutics, Inc. (A2 Bio) is a clinical-stage biotech company developing first-in-class logic-gated cell therapies to address the high unmet need in cancers. A2 Bio invented the proprietary Tmod™ cell therapy platform to tackle the fundamental challenge in cancer treatment—the ability of cancer medicines to distinguish between tumor and normal cells. A2 Bio has three Investigational New Drugs (INDs) in a truly first in human clinical stage personalized cell therapy studies EVEREST-1, EVEREST-2 and DENALI-1 with a 4th master pre-screening study BASECAMP-1 to identify and triage patients to both the Auto and Allogeneic Tmod cell therapy studies.  For more information, please visit the company’s website at www.a2bio.com.

Reporting to the Clinical Operations Senior Director the Clinical Operations Senior Manager will oversee clinical trials sponsored by A2 Biotherapeutics and support the growth and development of the Clinical Operations department. This individual will oversee all aspects of clinical trial conduct including study start-up, enrollment, maintenance, and close-out. This position is located in Agoura Hills, CA. 

Responsibilities include but are not limited to:

• Oversee all operational aspects of assigned clinical trial(s), including conduct such as study start-up, enrollment, study maintenance and close-out.
• Oversee internal (eg, direct reports, cross functional teams, etc.) and external functions (eg, CRO, vendors, clinical investigators, etc.) to ensure clinical operations deliverables are met within the expected timelines, within budget, and up to the standards of quality set by key stakeholders.
• Manage and track study timelines, budget, metrics, and milestones. Provide routine status updates and escalate risks to relevant stakeholders.
• Develop, review, approve, and/or oversee completion of the clinical documents below, including, but not limited to: 

• Clinical study protocol
• Informed Consent form template (master and/or country-level)
• Cell therapy product procedure manual and related forms
• Feasibility / cell journey logistics questionnaire
• Pre-site selection slides
• SIV training slides
• Protocol training material
• Clinical monitoring/management plan including report templates
• Safety management plan and SAE report form template
• Clinical laboratory manual and requisition forms
• CRFs and CRF completion guidelines
• IRT manual
• Central imaging manual
• Edit check / data review plan
• Data review board charter (eg, DSMB, SRT)
• ISF structure and template documents
• Other as needed study-specific documents, plans, charters, tools, trackers, etc. including that of CRO
• Lead internal study team meetings and other internal clinical operations meetings and/or working group meetings. Participates as the study operations representative in other study-specific or internal meetings.
• Manage and/or participate in the selection process of vendors and/or contractors supporting a study, including but not limited to:

• CRO
• Clinical trial monitors
• Central lab
• Central imaging
• EDC system
• IRT system

• Act as primary point of contact overseeing, managing, and tracking performance of vendors selected for a clinical study including budget review, invoicing, and the approval of study specific documents.
• Provide and/or ensure training for internal study teams, vendors, third party contractors, and sites.
• Travel and work cross functionally with Clinical Development, Medical Affairs, Regulatory Affairs, Quality and Technical Operations.
• May be assigned to oversee clinical studies that are considered to be higher in complexity (eg, umbrella and/or basket design, multi-region global studies) and/or higher in priority (eg, pivotal studies) as determined by the Clinical Operations Senior Director.
• Manage, oversee, and track performance of clinical sites selected for a clinical study.
• Offers sponsor review and approval of site-specific documents (eg, site-specific ICF, patient facing materials, etc.).
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• May lead the development, review and implementation of departmental SOPs and processes as determined by the Clinical Operations Senior Director.
• Contribute to the selection of contractors or FTEs
• Other duties as assigned.

Supervisory Responsibilities   

• Support hiring, leading and managing workflow and development of staff.
• Recruit and hire in accordance with the resourcing plan as determined by the Clinical Operations Senior Director.
• May provide mentorship for professional development of the CTMA/Sr. CTMA and/or other junior-level clinical operations team members.

Requirements

• Experience and/or knowledge of cell therapy clinical trial operations (eg, transplant patient care and apheresis collection) strongly preferred.
• Experience managing and selecting CROs and other clinical trial vendors (eg, central lab, central imaging, etc.).
• Thorough knowledge and understanding of ICH guidelines, GxPs for conduct of clinical trials, and FDA and EMA regulations.
• Excellent interpersonal, verbal and written communication skills, while being able to work and think independently, to support a collaborative work environment.
• Strong analytical and problem-solving skills; and be able to proactively identify and communicate risks and/or other issues and develop appropriate mitigation, action plans, or solutions in collaboration with key stakeholders.
• Strong clinical research knowledge and cross-functional understanding of clinical trial methodology with proven ability to execute clinical trials within expected timelines and budget.
• Ability to deal with time demands, incomplete information or unexpected events.
• Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Education and Experience

• BA/BS or equivalent degree, plus 3 years of direct experience in clinical operations supporting clinical drug development within the oncology and/or cell therapy space; OR minimum 7 years of direct experience in clinical operations supporting clinical drug. development with no experience in oncology and/or cell therapy clinical studies.
• Bachelor’s degree (BA or BS) from an accredited college or university.
• 5 years of direct experience in clinical operations supporting clinical drug development.
• 5 years of direct experience in clinical operations supporting clinical drug development with experience in oncology and/or cell therapy clinical studies.
• At least 5 years of direct trial management experience.
• Travel, direct site visit and congress travel experience to support Medical Affairs and Clinical Development.

Physical/Travel Requirements

•  May be required to travel by plane or car up to 25% of the time.
• This position requires travel to monitor clinical sites, to support physician engagement at sites, to support congresses, and to corporate meetings as needed.
• Periods of standing and walking throughout the department/CRO to observe and support the work of staff members/CRO member.
• Occasional lifting and/or moving up to 25 pounds. 
• Day-to-day work includes use of computers and other office equipment. 
• Occasionally reaching above shoulder level.
• Occasional evening and weekend work as needed.

Benefits

• Competitive base salary and annual incentive opportunities (annual salary range for this position $150,000 - $180,000).
• Equity participation
• Medical, dental and vision benefits
• Life, disability and accident coverage
• Health and wellness programs
• Paid time off and holidays
• Flexible work arrangements
• Paid parental leave
• Environment where professional development is actively encouraged and supported.