Manager, Clinical Quality Assurance

4 weeks ago

Cambridge, United States Bicycle Therapeutics Full time
Job DescriptionJob DescriptionCompany Description

Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in 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 role of Manager, Clinical Quality Assurance, supports Quality oversight for Bicycle’s development programs, ensuring compliance with applicable GLP and GCP standards and global regulations. This role is part of the  Development Quality group, reporting to the Head of Development Quality.

As an integral member of the quality  team,  you will serve as a Quality and compliance business partner, engaging with multiple collaborators. You must be comfortable working independently, managing interactions with and between team members, both internally and externally.

Key responsibilities

  • Partner with global program teams and supporting functions as required to advise on GLP and GCP  compliance,  proactively build quality into the operational activities
  • Assist key stakeholders to  build inspection readiness to all stages of the development process
  • Assist with the development and maintenance key quality indicators and introduce measurement of critical to quality factors, monitor performance against key KPIs both internally and across third parties.
  • Ensure monitoring of quality performance indicators, identification of key quality events, escalation of issues and support follow up activities
  • Support scoping of vendor evaluations and audits, contribute to reports and assist with follow up on assessment and partner with the business to  support the development of CAPAs.
  • Educate and partner with key stakeholders on Deviation identification and reporting as well as risk appropriate remediation , RCA and CAPA management
  • Assist functional area partners with development and documentation of CAPAs and effectiveness checks, as applicable.
  • Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.
  • Serve as POC for  QMS related training assignments for Development colleagues
Qualifications

  • Relevant qualification within healthcare or Life Sciences or equivalent professional experience
  • Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GLP/GCP quality/compliance role
  • Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS)
  • Strong familiarity with eTMF requirements
  • Extensive experience managing deviations, RCA and CAPAs in a GLP /GCP environment
  • Experience leading quality event investigations/ root cause analysis
  • A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing
  • Highly collaborative, strong relationship building skills with high level of integrity.
  • Demonstrated ability to work proactively using solid communication and influencing skills to effectively execute program goals
  • Exhibits flexibility and is a self-starter with a strong attention to detail
  • Demonstrated ability to adapt working style to those of others for effective communication; able to multi-task and support multiple teams with varying levels of complexity
  • Able to work effectively in highly complex and fast-paced environments
  • Strong organizational and time management skills
  • Familiarity with Electronic Document Management (EDM) systems and Microsoft Office suite
  • Position requires both domestic and international travel up to 10% of time


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 status, marital status, or veteran status.

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