Senior Manager, Clinical Trials

We are powering the age of immune medicine–you can too. At Adaptive, our goal is to harness the power of the adaptive immune system to make a difference in the lives of people living with many different diseases.

As an Adapter, you will be surrounded by driven colleagues who think boldly and innovate fearlessly. You will experience meaningful challenges in your work and be fueled by the knowledge that you’re making a difference in patient’s lives.

You belong here – come discover your story at Adaptive.

Position Overview

The Sr. Manager, Clinical Trials will be responsible for the end-to-end management of clinical trials for the company’s MRD Pharmaceutical clinical trials. This position will support and contribute to the Adaptive Biotechnologies Diagnostic (Dx) Customer Operations team to ensure that our customers and their patients have exceptional experience.

Key Responsibilities and Essential Functions

• Act as the Analytical Project Manager for all assigned clinical trials which includes preparing and managing the execution of highly detailed Analytical Plans and Bioanalytical Reports
• Contribute to relevant operational plans including clinical protocols, laboratory manuals, statistical analysis plans, DTAs, etc.
• Partner with internal Regulatory and Laboratory (lab) Operations Quality Assurance to ensure studies adhere to contractual regulatory obligations and stay current with global guidelines
• Develop and maintain strategic relationships with Business Development Alliance Managers, Computational Biology, Investigators and Sponsors. This position will serve as a liaison between study sponsors, investigative sites, and clinical research organizations
• Complete lifecycle management of assigned projects, onboarding of new clinical sites and physicians, regular progress check-ins, and prioritization of timelines and special requirements with internal stakeholders
• Coordinate with the lab operations personnel to develop required preparedness prior to study initiation
• Facilitate kick-off meetings as well as individualized clinical site presentations that provide project specific training for each assigned clinical trial protocol
• Ensure ongoing maintenance of regulatory documents in electronic Trial Master File (eTMF)
• Provide clinical trial sample forecast to Lab Operations and Dx Leadership
• Provide input and recommendations to executive leadership regarding investment of additional company resources when perceived as necessary to maintain service quality and/or compliance
• Provide strategic insights to leadership that will enable scaling activities of evolving clinical trial models
• Lead or participate in educational and training sessions, meetings and/or demonstrations for professional development of self and team members. Maintain current knowledge of relevant research areas through scientific and regulatory literature reviews. Participate in relevant national/international professional organizations

Position Requirements (Education, Experience, Other)

Required

• Bachelor plus 12 years of related experience or master’s degree plus 8 years of related experience; advanced coursework in biological sciences preferred
• 5-8 years of relevant Pharmaceutical/Biotech/CRO industry experience highly preferred 
• Prior experience with Clinical Trials is required
• 2 years of supervisory experience

Preferred  

• Proactive approach to work; strong personal drive and desire for feedback
• Strong customer and patient focus with a clear understanding of HIPAA requirements
• Must have strong analytical and planning skills with keen attention to detail and meticulous data entry skills
• Working knowledge of ICH-GCP and ability to comply with all regulatory requirements (CLIA/CAP, ISO, GxP)
• Effective project leader able to work autonomously to advance the team toward agreed-upon goals
• Ability to comprehend, deconstruct, and optimize complex operational workflows
• Strong interpersonal and organizational skills with excellent listening, oral and written communication skills
• Ability to engage directly with and provide well-supported recommendations to leadership
• Familiarity with basic laboratory and customer service-related systems such as LIMS and SFDC
• Working knowledge of NGS sequencing, standard molecular biology techniques and sample handling best practices

Compensation

Salary Range: 112,400 - $168,600

Other compensation elements include:

• equity grant
• bonus eligible

Interested in this position, but don’t meet all the requirement