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Senior Manager, Clinical Operations Quality Compliance

3 months ago

Cambridge, United States Bicycle Therapeutics Full time

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

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. They will support delivery of Clinical Operations activities by participating in Clinical Operations process improvement and development and supporting implementation of function-wide initiatives. They will lead investigations of GCP quality issues and ensure effective risk mitigations are established. In addition, they 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
  • Proven written and verbal communication skills required
  • Attention to detail and thorough follow-up skills
  • Ability to contribute and manage in a cross functional environment

Desirable:

  • Experience preparing for and participating in regulatory inspections (including clinical sites)
  • Experience in oncology clinical trials
  • Experience authoring SOPs, Work Instructions, and other controlled documents within a clinical development organization

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.

All your information will be kept confidential according to EEO guidelines.

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.