Vice President, Clinical Operations

Los Angeles, CA /
Clinical /
Full-Time
/ On-site
About our Company
Appia Bio is a preclinical stage biotech company founded in 2020 with the mission to bring innovative off-the-shelf cell therapies to cancer patients. Our novel platform can generate a broad array of allogeneic NKT and T cell types and can be engineered to address challenges in tumor microenvironments. Our goal is to discover and develop allogeneic cell therapies across a broad array of cancer indications with a scalability that increases access for patients.

Our research programs are rooted in leveraging T cell biology to generate NKT and T cell subtypes from hematopoietic stem cells. The scientific foundation of Appia Bio is underpinned by collaborative research led by Lili Yang (UCLA), David Baltimore (Caltech), and Pin Wang (USC), and further advised by a stellar scientific advisory board. The management team brings decades of experience in R&D, Technical Operations and business in the biotech industry.
 
About the Role
Appia Bio is seeking a Vice President of Clinical Operations to establish and lead our Clinical Operations organization and capabilities.  The individual will lead strategic planning and execution of clinical trials for our CAR-NKT products.   Through the duties and responsibilities below, the Vice President of Clinical Operations will play a critical role in the development of novel allogeneic cell therapies.  The successful candidate will join a culture of intellectual rigor and collegiality that we are building at Appia.

Responsibilities

    • Establishes and leads the Clinical Operations function; develops the overall clinical study operations strategy
    • Leads Clinical Operations activities to ensure clinical trial deliverables are completed on time, budget, and according to quality standards.  Monitors performance against key metrics and deliverables
    • Provides leadership and oversight of internal staff, CROs and external consultants
    • Develop and manage clinical timelines and budget
    • Establishes vendor scope of work, quality, and budget.  Establishes vendor metrics and conducts review in support of quality delivery
    • Development, management, and maintenance of study deliverables through collaboration with internal and external stakeholders.  Contribute to the preparation, review, and submission of appropriate and consistent clinical study documents
    • Ensures compliance with SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of clinical trial execution; contribute to the development of stage appropriate clinical SOPs and GCPs
    • Provides proactive assessment of clinical trial risk and develops plans for risk mitigation
    • Drive efficiency through proactive management of cost drivers
    • Maintain knowledge and monitor changes regarding innovative approaches to clinical trial operations
    • Develop strong relationships and communicate effectively with the Research, Technical Operations, Regulatory Affairs, and Clinical Development teams
    • Reports to the Chief Medical Officer

Minimum Requirements

    • Bachelor's degree in a scientific discipline
    • A minimum of 10 years of clinical trial management experience across biotech and pharma
    • Consistent track record of success leading complex trials with CRO partnerships; experience in planning and execution of clinical trials on time, within budget, and in compliance
    • Working knowledge of clinical research regulations in multiple regions
    • Experience in successfully building and managing a clinical operations team (internal and external)
    • Highly motivated self-starter with strong presence, work ethic, and focus
    • Outstanding communication skills with the ability to build transparent and collaborative relationships across the company and with other stakeholders of the company

Preferred Requirements

    • Oncology experience and expertise. Cell therapy, gene therapy or immuno-oncology also preferred
Benefits
Competitive Compensation Packages | Cost Sharing for Health Insurance Premiums | Flexible Work Environment | Untracked PTO | 401(k) Retirement Savings Plan Match | Life Insurance & Disability| Awesome Culture | Challenging & Fulfilling Work | Equity Options | and more

Appia Bio requires COVID-19 vaccination for all employees. As required by applicable law, we will consider requests for reasonable accommodations.
 
The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Appia Bio is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.