Senior Manager, Clinical Operations Quality Compliance (GCP)

Company Description

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.  
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination. 
• We are One Team. We only succeed when we work together. 

Job Description

Bicycle Therapeutics, Inc. is seeking a knowledgeable, resourceful and collaborative Clinical Quality Compliance Manager within Clinical Operations. The Senior Manager, Clinical Operations Quality Compliance collaborates with Clinical Operations, Clinical Quality, Clinical Development, Medical Affairs, Safety, and other functions to help maintain compliance with processes, ensure regulatory compliance and promote the highest standards of quality and integrity in Clinical Operations. You will support delivery of Clinical Operations activities by participating in Clinical Operations process improvement and development and supporting implementation of function-wide initiatives. You will lead investigations of GCP quality issues and ensure effective risk mitigations are established. In addition, you will support the oversight of Clinical Operations processes, training, and inspection readiness activities and tools and participate in regulatory inspection activities. 

• Provide ICH/GCP clinical compliance support to Clinical Operations and their stakeholders. Maintain current knowledge related to ICH/GCP guidelines and regulations and Bicycle standard operating procedures. 

• Collaborate and develop strong relationships with personnel from Clinical Operations, Clinical Quality, and other cross functional stakeholders to facilitate and support process improvement, risk management, and inspection readiness activities. 

• Collaborate with Clinical Quality to ensure that Clinical Operations written standard operating procedures, forms, and templates reflect appropriate business practices and meet the changing needs of the organization. 

• Establish standards for excellence in GCP investigation documentation, inspection preparation and responses, CAPAs, and effectiveness checks to optimize effective and consistent performance. Assist with resolution of quality events, deviations, audit and inspection findings.  

• Support the clinical operations team in root cause analysis and facilitating closure/evidence of completion of assigned Clinical Operations corrective action commitments; confirm that all actions and commitments related to inspections are implemented in accordance to plan and support effectiveness checks 

• Support Clinical Operations initiatives (including lessons learned process) to develop innovative processes and technologies to advance compliant operations 

• Facilitate and support inspection readiness activities in Clinical Operations  

• Provide support before, during and following regulatory inspections and internal audits involving clinical operations 

• Identify and escalate significant quality and compliance risks to leadership within Clinical Operations, Clinical Development and Clinical Quality 

• Participate in due diligence activities and process improvement initiatives as requested by management 

• Other duties and responsibilities as required 

Qualifications

Essential:  

• Bachelor’s degree in scientific, biological, life sciences, or related field.  

• Direct clinical operations or clinical quality assurance experience at a CRO or pharmaceutical company 

• Strong knowledge and understanding of ICH/GCP/local regulations and applicability to trial(s) 

• Knowledge of current regulatory requirements and guidelines governing clinical research and related terminology 

• Excellent strategic thinking, organizational, analytical, planning, and project management skills  

• Possess a strong commitment to quality and accuracy 

• Self-starter and a team-player who thrives in a fast-paced environment 

• Ability to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrity 

• Fosters open and transparent communication 

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