Senior Director, Quality

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 Cambridge, 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

The Senior Director, Quality will be responsible for leading Quality strategy and execution across clinical development, spanning candidate selection through to registration and product launch.

• Serve as both the strategic and operational leader to direct, oversee and manage all clinical quality assurance activities.
• Provide leadership, direction and mentorship across all levels of the organization to assure quality assurance strategies are understood and implemented.
• Collaborate with various functions to determine appropriate quality improvement and compliance priorities and plans.
• Lead the development and subsequent maintenance of a phase-appropriate, company-wide electronic Quality Management System (eQMS) that meets internal company standards and external regulatory and customer requirements.
• Partner with IT to ensure that digital strategies employ appropriate data integrity principles.
• Ensure compliance to regulatory guidance through all stages of clinical and product development.
• Ensure processes are developed, maintained, and reviewed than ensure Bicycle sponsored clinical trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
• Partner with regulatory affairs to assess new and emerging regulations and apply in a fit for purpose manner to Bicycle’s QMS and practices and anticipate any changes that may impact the development strategies for programs.
• Collaborate with Regulatory Affairs to ensure regulatory submissions compliant to GxP and global regulations.
• Coordinate the preparation, and management of regulatory agency inspections, including vendor inspections and Pre-Approval inspections.

Qualifications

• Strong background in Quality and Compliance with a strong understanding of both FDA and EU regulations, in a clinical development setting.
• Ability to apply technical expertise of GxP to align the Quality strategy with Bicycle’s company strategy, to set functional Quality and Improvement goals.
• Exceptionally strong and wide-ranging understanding of contemporary quality and regulatory requirements.
• Wide ranging experience of working with complex organic molecules from candidate selection through to regulatory submission and subsequent commercial launch.
• Strong leadership skills with the ability to inspire and develop diverse teams internally.
• Highly collaborative, strong relationship building skills with a high level of integrity and emotional intelligence.
• First class communication and influencing skills with the ability to manage multiple stakeholders.
• Resilient and able to work effectively in a demanding and fast-paced environment.   

Additional Information

• Flexible working environment
• Competitive reward including annual company bonus 
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company 
• Health and Dependent Care Flexible Spending Accounts 
• 401(k) plan with a 4% Company match and immediate vesting 
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days 
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays 
• Competitive Family Leave Policy 
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. 

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability stat