Clinical Operations Senior Director

Clinical Operations Senior Director

Los Angeles, California, United States

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 Senior Medical Director in Clinical Development and dotted line to the Senior Medical Director of Safety and Medical Affairs. The Clinical Operations Senior Director will provide leadership and strategic oversight of clinical trial operations; and will integrate clinical operations expertise into the long-term strategy and vision for the clinical development of A2 Bio cell therapy programs. This individual will form, establish, and maintain effective relationships with cross-functional and external partners (e.g., CROs, investigators, KOLs, etc.) for collaboration on current projects and long-term strategy. This position will also lead the growth and development of talent within the clinical operations department. This position is located in Agoura Hills, CA.

• Effectively apply clinical operations knowledge and expertise into all clinical development activities, such as integrated clinical development planning, clinical protocol development, regulatory submissions (e.g., IND, BLA filing, IR responses), global expansion, etc. Apply new learnings where it makes sense to add value to existing plans or other activities.
• Lead clinical operations across multiple clinical programs to ensure deliverables are met within the expected timelines, within budget goals, and up to the standards of quality set by key stakeholders.
• Provide strategic oversight of clinical operations to ensure long-term clinical deliverables are set-up for success within expected timelines, projected budget, while maintaining quality and integrity.
• Establish and maintain effective relationships with key partners to support current clinical activities and strategy to ensure consistent alignment to the long-term vision for the A2 cell therapy programs.
• Represent and advocate for clinical operations on governance bodies or in other decision-making forums. Represents A2 Bio clinical operations in governance bodies with external vendors (e.g., CRO, central lab, central imaging, etc.).
• Provide key contributions to the development or amendment of the clinical documents below, including, but not limited to: 
• Clinical study protocol
• Informed Consent form template (master)
• Investigator's Brochure
• General Investigational Plan
• Clinical Study Report
• Feasibility / cell journey logistics questionnaire
• TFL shells
• SIV training slides
• Cell therapy product procedure manual and related forms
• Templates of all other as needed study-specific documents, plans, charters, tools, trackers, etc. including that of CRO
• Publications

• Oversee the selection process and approving vendors and/or contractors supporting a study, including but not limited to:

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

• Collaborate with CQA to establish and maintain quality systems to ensure clinical studies are conducted in strict compliance with GCP, regulations, and company SOPs.
• Establish performance indicators and benchmarks for “healthy” clinical programs and company culture; and proactively identify and escalate potential issues/risks through the proper channels.
• Provide accurate enrollment, budget, and resourcing forecasts for current clinical programs and future planning, including hypothetical scenarios.
• Other duties as assigned.

Supervisory Responsibilities    

• Hire, lead and manage workflow and development of staff.
• Mentor clinical operations staff to ensure individual professional development plans are fulfilled.
  

Requirements

• Experience and/or knowledge of cell therapy clinical trial operations (e.g., transplant patient care and apheresis collection) in early to late stage (e.g., IND to BLA) oncology clinical trials strongly preferred.
• Experience managing direct reports and resource planning.
• Experience managing and selecting CROs and other clinical trial vendors (e.g., central lab, central imaging, etc.).
• Thorough knowledge and understanding of ICH guidelines, GxPs for conduct of clinical trials, and FDA and EMA regulations.
• Travel and lead cross functional Operation meetings with Clinical Development, Medical Affairs, Regulatory Affairs, Quality and Technical Operations.
• 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 multitask and prioritize.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Education and Experience

• Bachelor’s degree (BA or BS) from an accredited college or university.
• 10-15 years of direct experience in clinical operations supporting clinical drug development.
• 10 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, ideally 10 years of 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 members. 
• 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 $220,000 - $250,000).
• 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.